Himalaya Pink Salt Purple Color Corrector Plus Intensive Whitening Toothpaste

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 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 should 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 are advised to supervise children's brushing 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 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 the reach of children under 6 years of age to prevent accidental ingestion. The product is not intended for swallowing; therefore, users should be advised against this practice.

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 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 essential to ensure patient safety and to facilitate timely intervention if necessary.

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 allergic responses and to take appropriate action as necessary.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Himalaya Pink Salt Purple Color Corrector Plus Intensive Whitening Toothpaste (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 is advised that they do not swallow it. In the event of accidental ingestion of more than the amount used for brushing, professional assistance or contact with a poison control center is recommended 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. Parents and 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 prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available 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 using this medication.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the medication.

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 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 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 on the appropriate steps to take. Prompt intervention is essential to mitigate any potential adverse effects associated with the overdosage.

Monitoring for symptoms related to the overdosage may be necessary, although specific symptoms are not detailed in the provided information. Therefore, vigilance in assessing the patient's condition and any emerging symptoms is recommended.

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 limits the assessment of potential risks associated with the compound in these areas.

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 of the product immediately if they experience any signs of an allergic reaction. This proactive communication can help ensure patient safety and promote appropriate use of the product.

Storage and Handling

The product is supplied in a tube that must be kept tightly closed when not in use to maintain its integrity. It should be stored at room temperature, ensuring that it is not exposed to freezing conditions. If the product is not used within a specified time frame after opening, it should 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 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 Toothpaste, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)