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 9X whiter teeth and offers 24-hour stain resistance. Additionally, this toothpaste is designed to strengthen enamel. The product is available in 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 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 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 who develop an allergic reaction; in such cases, discontinuation of use is required immediately.

Additionally, the product should not be ingested. If accidental ingestion occurs, particularly in amounts exceeding the recommended usage for brushing, it is imperative to 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 greater than 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 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

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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, 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 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 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

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 potential 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 medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication. It is recommended to weigh the potential benefits against any unknown risks to the nursing infant.

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 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 an amount exceeding that which 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 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 prepared to manage any complications that may arise from excessive ingestion.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical 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 of the product immediately if any signs of an allergic reaction develop. 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 a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, away from extreme temperatures, and must be protected from freezing.

To maintain the quality of the product, the tube should be kept tightly closed when not in use. Additionally, it is important to discard the product after opening if it is not utilized within the specified time frame, which is not detailed in the provided information.

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. 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)