Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 72476-213

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Retail Business Services, Llc for the product Anticavity Fluoride Rinse (NDC 72476-213). 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, inactive ingredient, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity rinse

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, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on the inside of cap); do not fill above the 10 mL mark
  • vigorously swish 10 milliliters 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 Ingredient

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Other Information

• store at room temperature

Disclaimer

This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse

SEALED WITH PRINTED NECKBAND FOR YOR PROTECTION

Adverse Reactions

DISTRIBUTED BY:

American Sales Company

4201 Walden Avenue, Lancaster, NY 14086

Principal Display Panel

Compare to the Active Ingredients in ACT

CAREONE

ANTICAVITY

FLUORIDE

RINSE

MINT FLAVOR

  • Strong Cavity Protection

    • IMPORTANT: Read directions for proper use

    18 FL OZ (532 mL)

    Image Description (Mm1)

    Image Description (Mm1)

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