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Distributed by:
KENVUE BRANDS LLC
Summit, NJ 07901
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash Mouthwash
FDA Label NDC 69968-0904
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash (NDC 69968-0904). 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 other, active ingredient, purpose, use, otc - 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
Sodium fluoride 0.02% (0.01% w/v fluoride ion)
Purpose
Anticavity
Use
Aids in the prevention of dental cavities
Otc - Keep Out Of Reach Of Children
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 a day after brushing your teeth with a toothpaste.
- Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and 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 a doctor.
Other Information
- Store at room temperature
- Cold weather may temporarily cloud this product
Inactive Ingredients
Water, Sorbitol, Flavor, Phosphoric Acid, Cetylpyridinium Chloride, Sucralose, Sodium Saccharin, Disodium Phosphate, Red 33, Green 3
Questions?
call toll-free 888-222-0182 or 215-273-8755 (collect).
Principal Display Panel - 500 Ml Bottle Label
ALCOHOL FREE
ADA
Accepted
American
Dental
Association ®
24-HR CAVITY
PROTECTION †
†when used twice daily
kid-approved taste
ANTICAVITY FLUORIDE RINSE
LISTERINE®
TOTAL CARE KiDS
SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION
6IN1
BENEFITS*
BERRY
SPLASH
KID-APPROVED
TASTE
500mL(16.9Fl Oz)
IMPORTANT: Read
directions for proper use.
69968-0904 (69968 0904)
* Please review the disclaimer below.
