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Hello Sugar

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Active ingredient
Lidocaine Hydrochloride 5 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
November 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 5 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
November 12, 2025
Manufacturer
Sambria Pharmaceuticals, LLC
Registration number
M017
NDC root
54723-031
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

You can use this medication for the temporary relief of pain and discomfort. It is designed to help alleviate your symptoms, providing you with some comfort when you need it most. If you're experiencing pain, this medication may be a suitable option to consider for short-term relief.

Uses

You can use this medication for the temporary relief of pain and discomfort. It is designed to help you feel better when you're experiencing these symptoms.

Additionally, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects (which refers to effects that do not cause harm to the fetus). This makes it a safer option for those who may be pregnant or planning to become pregnant.

Dosage and Administration

To use this medication effectively, start by cleaning the affected area with mild soap and warm water. Make sure to rinse it thoroughly and gently dry the area by patting or blotting it with tissue or a soft cloth. This preparation helps ensure the medication works properly.

For adults, apply the medication directly to the affected area on your skin. It's important to keep this product out of reach of children under 12 years old to ensure their safety. Always follow these steps to get the best results from your treatment.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance) or any explicit instructions advising against its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid applying it to broken skin or if you have an allergy to any of its ingredients. If you experience worsening symptoms or if your condition does not improve after 7 days, stop using the product and consult your doctor. Additionally, keep it away from children and pets, and seek immediate medical help if it is swallowed.

Always follow the directions carefully and avoid contact with your eyes, rashes, or mucous membranes to minimize any adverse reactions.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to broken skin or if you have an allergy to any of its ingredients. When using the product, follow the instructions carefully and steer clear of contact with your eyes, rashes, or mucous membranes.

If your condition worsens, or if symptoms last longer than 7 days or come back after treatment, stop using the product and consult your doctor. Additionally, keep this product out of reach of children and pets. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

It's important to keep this medication out of reach of children and pets. If someone accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center.

Signs of an overdose can vary, but if you suspect that an overdose has occurred, do not hesitate to get help. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine hydrochloride cream during pregnancy has not been established. Its use is generally not recommended due to potential risks to your developing baby (fetus). There may be specific risks associated with using this cream while pregnant, so it's crucial to consult your healthcare provider before using it.

If you do need to use this product, make sure to discuss it with your healthcare provider first. They can help determine if it's necessary and may suggest dosage modifications to ensure your safety and that of your baby. Always prioritize open communication with your healthcare team regarding any medications during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or precautions regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this medication away from children under the age of 12. This precaution helps ensure their safety, as the effects and appropriate dosages for younger children may not be well understood. Always consult with a healthcare professional if you have questions about using this medication for children or if you need guidance on alternatives.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your specific health needs.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, it's important to store it in a cool, dry place, away from excessive heat and direct sunlight. This will help maintain its effectiveness and safety.

When handling the product, always do so with care to avoid any damage. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

The medication is administered topically, meaning it is applied directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any specific questions about how to use this medication or its effects, be sure to consult your healthcare provider for more information.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of pain and discomfort.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended due to potential risks to the fetus.

What should I do if I experience worsening symptoms?

Stop use and ask your doctor if your condition worsens or if symptoms persist for more than 7 days or return.

Can this drug be used on broken skin?

No, you should not use this product on broken skin or if you are allergic to any ingredient.

How should I apply this drug?

Cleanse the affected area with mild soap and warm water, then gently dry before applying the drug externally to the affected area.

What precautions should I take when using this drug?

Use only as directed, avoid contact with eyes, rashes, or mucous membranes, and keep out of reach of children and pets.

What should I do if this product is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

Is there any information about using this drug while nursing?

There are no specific warnings or precautions mentioned regarding the use of this product in nursing mothers.

Packaging Info

Below are the non-prescription pack sizes of Hello Sugar (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hello Sugar.
Details

Drug Information (PDF)

This file contains official product information for Hello Sugar, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and discomfort.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

When practical, the affected area should be cleansed with mild soap and warm water, followed by thorough rinsing. The area must then be gently dried by patting or blotting with tissue or a soft cloth prior to application.

For adults, the product is to be applied externally to the affected area. It is important to keep this product out of reach of children under 12 years of age.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients not to apply the product to broken skin or in cases of known allergies to any of its ingredients.

When utilizing this product, it is essential to adhere strictly to the directions provided. Care should be taken to avoid contact with the eyes, rashes, or mucous membranes, as such contact may lead to adverse effects.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms return after a period of improvement.

Additionally, it is crucial to keep this product out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on broken skin or in individuals with known allergies to any of its ingredients. Participants are advised to follow the usage instructions carefully, avoiding contact with the eyes, rashes, or mucous membranes.

In the event that the condition worsens, or if symptoms persist for more than 7 days or return, patients should discontinue use and consult a healthcare professional. Additionally, it is crucial to keep this product out of reach of children and pets. If ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Hello Sugar (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hello Sugar.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Caution is advised to ensure that it is kept out of reach of this age group to prevent accidental ingestion or misuse.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Safety during pregnancy has not been established for the use of lidocaine hydrochloride cream. Its use is not recommended during pregnancy due to potential risks to the fetus. There may be risks associated with the application of this product, and therefore, pregnant patients should only use it if clearly needed and after a thorough discussion with their healthcare provider.

Healthcare providers should consider consulting with pregnant patients regarding dosage modifications if the use of lidocaine hydrochloride cream is deemed necessary. It is essential to weigh the potential benefits against the risks to fetal outcomes before proceeding with treatment.

Lactation

There are no specific warnings or precautions regarding the use of this product in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children and pets to prevent accidental ingestion. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay for further guidance.

Prompt action is crucial in managing potential overdosage situations. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise.

Management procedures may include supportive care and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and provide appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include rash, itching, and hives; as well as local skin reactions characterized by redness and irritation at the application site.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young children.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to protect the product from excessive heat and direct sunlight to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The route of administration for the medication is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Hello Sugar, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Hello Sugar, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.