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. This product features a vanilla mint flavor and is designed to provide a 2.9X tone-up effect and a 9.6X whitening effect. It offers 24-hour stain resistance and contributes to enamel strengthening. The net weight of the product is 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. Should an allergic reaction occur, discontinue use immediately.

Additionally, the product should not be ingested. 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 potential risks associated with excessive consumption.

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 and well-being 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.

Clinical trials and postmarketing experiences have not indicated any additional serious adverse reactions beyond those typically associated with allergic responses. Continuous monitoring for any signs of hypersensitivity is recommended to ensure patient safety.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug 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, and it should not be swallowed. In the event of accidental ingestion of more than the amount used for brushing, professional assistance or contact with a poison control center is advised immediately.

For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years. Parents and caregivers are encouraged to 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 and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for HIMALAYA PINK SALT PURPLE COLOR CORRECTOR PLUS INTENSIVE WHITENING VANILLA MINT toothpaste. Therefore, the effects on breastfed infants and the excretion of the product in breast milk are not established. Lactating mothers should consult with their healthcare provider for personalized advice regarding the use of this product while breastfeeding.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 imperative that healthcare professionals take immediate action. If a patient accidentally ingests more than the recommended amount used for brushing, it is crucial to seek professional assistance without delay.

Healthcare providers should advise patients or caregivers to contact a poison control center immediately for guidance. Prompt intervention is essential to mitigate potential adverse effects associated with overdosage.

Monitoring for symptoms related to overdosage is also important, although specific symptoms are not detailed in the provided information. Therefore, healthcare professionals should remain vigilant and assess the patient for any unusual signs or reactions following an overdosage incident.

In summary, swift action and professional consultation are vital in managing cases of overdosage to ensure patient safety and effective care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

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 they experience any signs of an allergic reaction.

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, it is important to discard the product after opening 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 caregivers should supervise brushing until proper habits are established. 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)