Label: MOUTH RINSE- sodium fluoride mouthwash
- NDC Code(s): 36800-001-86
- Packager: Topco associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Claims
- Active ingredient
- Purpose
- Use
- WARNINGS
- Keep out of reach of children.
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Directions
Adults and children under 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 anything 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
- Other information
- Inactive ingredients
-
Disclaimer
*This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributed of Listerine Total Care Fresh Mint Anticavity Mouthwash.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
TOPCO VIJA0219 QUESTIONS? 1-888-423-0139 topcare@topco.com
This TOP CARE product is laboratory tested to guarantee its hightes quality. Your total satisfaction is guaranteed
DSP-TN 15000 DSP-MO-34 SDS-TN-15012
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PRINCIPAL DISPLAY PANEL
COMPARE TO LISTERINE TOTAL CARE FRESH MINT ANTICAVITY MOUTHWASH
TopCare
everyday
FLUORIDE
Anticavity
Mouthwash
SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION
EUCALYPTUS MINT
6 Benefits
- Helps prevent cavities
- Strengthes teeth
- Restores enamel
- Kills bad breath germs
- Freshens breath
- Cleans entire mouth*
*This product is not intended to replace brushing or flossing
IMPORTANT: Read directions for proper use.
33.8 FL OZ (1 QT 1.8 FL OZ) 1 L
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INGREDIENTS AND APPEARANCE
MOUTH RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SORBITOL (UNII: 506T60A25R) 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:36800-001-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 12/30/2010 Labeler - Topco associates LLC (006935977) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(36800-001)