Anticavity Fluoride Rinse
FDA Label NDC 11344-163

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Anticavity Fluoride Rinse (NDC 11344-163). 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 the reach of children, directions, store, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium Fluoride 0.0221% (0.01% Fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

WARNINGS

Keep Out Of The 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 12 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
• supervise children as necessary until capable of using without supervision
• children under 12 years of age: consult a dentist or doctor

Store

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

Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Other

This product is not manufactured or distributed by Johnson + Johnson Healthcare Products,
distributor of Listerine Total Care Fresh Mint Anticavity Mouthwash.

Adverse Reactions

Distributed by:

Vi-Jon, LLC

One Swan Drive

Smyrna, TN 37167

Principal Display Panel

Sealed With Printed Neckband For Your Protection

Swan

ANTICAVITY

Fluoride

Rinse

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

eucalyptus mint

  • Restores Enamel
  • Freshens Breath
  • Helps Prevent Cavities
  • Helps Strengthen Teeth
  • Helps Kill Germs That Cause Bad Breath

    • Compare to the active ingredient of Listerine Total Care Fresh Mint Anticavity Mouthwash

    IMPORTANT: READ DIRECTIONS FOR PROPER USE

    1 LITER (33.8 FL OZ)

    Image Description (Mm01)

    Image Description (Mm01)

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