Himalaya Pink Salt Purple Color Corrector Plus Intensive Whitening Vanilla Mint

Description

Himalaya Pink Salt is a fluoride anticavity toothpaste formulated with a purple color corrector and intensive whitening properties. It features a vanilla mint flavor and is designed to provide a 2.9X tone-up effect and 9.6X whitening capability. The toothpaste offers 24-hour stain resistance and enamel strengthening benefits. Each tube contains a net weight of 3.5 oz (100 g).

Uses and Indications

This drug is indicated for the protection against dental cavities.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist. It is important that the product is not swallowed.

For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers should supervise the brushing of children's teeth until proper brushing habits are established.

For children under 2 years of age, it is recommended to consult a dentist for appropriate guidance on dental care.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its components. If an allergic reaction occurs, discontinue use immediately.

Additionally, the product should not be swallowed. In the event of accidental ingestion beyond the recommended amount for brushing, seek professional medical assistance or contact a poison control center without delay.

Warnings and Precautions

It is imperative to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. The product is not intended for swallowing; therefore, users should exercise caution during application.

In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is crucial to seek professional medical assistance or contact a poison control center immediately. Prompt action is essential to ensure safety and mitigate any potential adverse effects.

Should any signs of an allergic reaction occur, the use of the product must be discontinued without delay. Monitoring for symptoms of an allergic response is advised to ensure the safety of the user.

Side Effects

Patients may experience adverse reactions during treatment. In the event of an allergic reaction, it is imperative to discontinue use immediately.

No additional serious or common adverse reactions have been specified in the available data. It is essential for healthcare providers to monitor patients for any signs of adverse effects and to provide appropriate guidance should an allergic reaction occur.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Himalaya Pink Salt Purple Color Corrector Plus Intensive Whitening Vanilla Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. It is important that children do not swallow the product. In the event of accidental ingestion of more than the amount used for brushing, immediate professional assistance or contact with a poison control center is advised.

For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years. Caregivers should supervise children's brushing until proper oral hygiene habits are established. For children under 2 years of age, consultation with a dentist is recommended prior to use.

Geriatric Use

There is no specific information available 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

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, it is crucial for healthcare professionals to act promptly. If a patient accidentally ingests more than the recommended amount used for brushing, immediate action is required.

Recommended Actions Healthcare providers should advise the patient or caregiver to seek professional assistance without delay. Contacting a poison control center is also strongly recommended to ensure appropriate guidance and management.

Potential Symptoms While specific symptoms of overdosage are not detailed, it is essential to monitor the patient for any unusual reactions or adverse effects following excessive ingestion.

Management Procedures Upon receiving a report of overdosage, healthcare professionals should assess the patient's condition and provide supportive care as necessary. Continuous monitoring and evaluation may be warranted based on the severity of the situation and the guidance provided by the poison control center.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to instruct patients not to swallow the product during use.

In the event that a patient accidentally swallows more than the amount used for brushing, they should seek professional assistance or contact a poison control center immediately.

Additionally, healthcare providers should inform patients to discontinue use immediately if any allergic reaction develops. This includes symptoms such as rash, itching, or difficulty breathing, and patients should be encouraged to report any such reactions promptly.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of reach of children under 6 years of age and to avoid swallowing. In the event of accidental ingestion of more than the amount used for brushing, patients should seek professional assistance or contact a poison control center immediately. If an allergic reaction occurs, use should be discontinued right away. For children under 6, it is recommended to use a pea-sized amount to minimize swallowing, and parents should supervise brushing until proper habits are established. Additionally, for children under 2 years, consultation with a dentist is advised.

Drug Information (PDF)

This file contains official product information for Himalaya Pink Salt Purple Color Corrector Plus Intensive Whitening Vanilla Mint, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)