Anticavity Mouthwash
FDA Label NDC 55301-163

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Your Military Exchanges for the product Anticavity (NDC 55301-163). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Other

→ Principal Display Panel

Active Ingredient

Sodium fluoride 0.0221%

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep Out Of Reach Of Children.

If more than ued for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older:
•use twice daily afttr brushing your teeth with toothpaste
•vigorously swish 10mL (2 teaspoonfuls) of rinse between
your teeth for 1 minute and then spit out
•do not swallow the rinse
•supervise children as necessary until capable of using without supervision
•children under 12 years of age: consult a dentist or doctor

Other Information

•store at controlled room temperature 20⁰ -25⁰C (68⁰- 77⁰ F)
•cold weather may temporarily cloud this product

Inactive Ingredients

water, sorbitol solution, alcohol (21.6%), flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, sucralose and/or sodium saccharin, dibasic sodium phosphate, D+C red no.33, FD+C blue no.1, yellow no.6