Alcohol-free Anticavity Liquid
FDA Label NDC 55301-482

12 label sections · Submitted to the FDA by Your Military Exchanges · 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 Alcohol-free Anticavity (NDC 55301-482). 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 tamper evident statement, claim, active ingredient, purpose, use, warnings, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Tamper Evident Statement

→ Claim

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ Keep Out Of Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Disclaimers

→ Adverse Reaction

→ Principal Display Panel

Tamper Evident Statement

SEALED WITH PRINTED NACKBAND FOR YOUR PROTECTION

Claim

ALCOHOL FREE

FLUORIDE MOUTHWASH

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

for this product

Keep Out Of Reach Of Children.

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

Directions

Adults and children 6 years of age and older:

use twice daily after brushing your teeth with a toothpaste
vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision
children under 6 years of age: consult a dentist or doctor

Inactive Ingredients

water, glycerin, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Disclaimers

This rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ^®Pro-Health ^®Advanced Anticavity Fluoride Mouthwash Enamel Care Alcohol Free.

**This product is not intended to replace brushing or flossing.