Label: ANTICAVITY- sodium fluoride mouthwash
- NDC Code(s): 72476-005-86
- Packager: RETAIL BUSINESS SERVICES , LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- WARNINGS
- Keep out of reach of children.
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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 and 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
- Other information
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SPL UNCLASSIFIED SECTION
Sealed With Printed Neckband For Your Protection
*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care anticavity Mouthwash.
DISTRIBUTED BY:
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949
2013 S&S BRANDS, LLC
Quality guaranteed or your money back
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Principal display panel
Compare to the Active Ingredient of Listerine Total Care Fresh Mint Anticavity Mouthwash*
CARE ONE
ANTICAVITY MOUTH WASH
SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
MINT FLAVOR
- Helps prevent cavities
- Restores enamel
- Helps strengthen teeth
- Helps kill germs that cause Bad breath
- Freshen Breath
IMPORTANT: Read directions for proper use
33.8 FL OZ (1 L)
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) EUCALYPTOL (UNII: RV6J6604TK) METHYL SALICYLATE (UNII: LAV5U5022Y) MENTHOL (UNII: L7T10EIP3A) PHOSPHORIC ACID (UNII: E4GA8884NN) SACCHARIN SODIUM (UNII: SB8ZUX40TY) THYMOL (UNII: 3J50XA376E) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SUCRALOSE (UNII: 96K6UQ3ZD4) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72476-005-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/12/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/12/2005 Labeler - RETAIL BUSINESS SERVICES , LLC (967989935) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(72476-005)