Himalaya Pink Salt Intensive Whitening Spearmint

Description

Himalaya Pink Salt is an intensive whitening fluoride anticavity toothpaste formulated with spearmint flavor. It is clinically proven to provide a whitening effect that is 9 times whiter, while also offering 24-hour stain resistance. The formulation is designed to strengthen enamel, contributing to overall dental health. Each tube contains a net weight of 4.2 ounces (120 grams).

Uses and Indications

This drug is indicated for the protection against cavities.

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

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 to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount of the product should be used to minimize the risk of swallowing. Caregivers should supervise the brushing process until proper oral hygiene 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 necessary 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 essential to ensure the 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.

Monitoring for signs of hypersensitivity is essential, and healthcare providers should be vigilant in assessing patients for any symptoms indicative of an allergic response.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Intensive Whitening Spearmint (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, professional assistance or contact with a poison control center should be sought immediately.

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 good oral hygiene habits are established. For children under 2 years of age, consultation with a dentist is advised before use.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of this medication 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

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The safety of this product during lactation has not been established.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If a patient accidentally ingests an amount greater than what is typically 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 manage potential risks associated with overdosage effectively.

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, immediate professional consultation and contact with a poison control center are the recommended actions in the case of overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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, once opened, the product must be discarded to ensure 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 at once. 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. 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 Intensive Whitening Spearmint, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)