Anticavity Mouthwash
FDA Label NDC 53942-163

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Demoulas Super Markets, Inc. for the product Anticavity (NDC 53942-163). 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, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 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

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, FD+C yellow no. 6

Other Information

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

Other

*This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine Total Care

DISTRIBUTED BY
DEMOULAS SUPER MARKETS, INC
875 EAST STREET
TEWKSBURY, MA 01876

DSP-TN-15000 DSP-MO-34 SDS-TN-15012

Principal Display Panel

Sealed With Printed Neckband For Your Protection

MARKET BASKET

MORE FOR YOUR DOLLAR

Compare to Listerine Total Care Anticavity Mouthwash*

ANTICAVITY MOUTHWASH

Sodium Fluoride and Acidulated Phosphate Topical Solution

Eucalyptus Mint

• Helps prevent cavities
• Helps strengthen teeth
• Helps kill germs that cause bad breath
• Freshens breath
• Restores enamel

IMPORTANT: Read directions for proper use.

1L (33.8 FL OZ)

163.004/163AE

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Image Description (Mm01)

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