Label: LISTERINE TOTAL CARE ZERO ALCOHOL ANTICAVITY FRESH MINT- sodium fluoride mouthwash
- NDC Code(s): 69968-0194-1, 69968-0194-2, 69968-0194-5, 69968-0194-9
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
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 January 4, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
-
Directions
- Adults and children 6 years of age and older:
- use twice daily after brushing your teeth with a toothpaste
- vigorously swish 10mL (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 doctor
- Adults and children 6 years of age and older:
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label
ANTICAVITY FLUORIDE MOUTHWASH
LISTERINE®
TOTAL CARE
IMPORTANT: READ DIRECTIONS FOR PROPER USE
SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION
ZERO ALCOHOL
6 IN 1
BENEFITS
- 24-HOUR CAVITY PROTECTION+
- RESTORES ENAMEL
- STRENGTHENS TEETH
- FRESHENS BREATH
- CLEANS WHOLE MOUTH
- KILLS BAD BREATH GERMS
+when used twice daily *bad breath germs
1.0L (1 Qt 1.8 Fl Oz)
FRESH MINT
-
INGREDIENTS AND APPEARANCE
LISTERINE TOTAL CARE ZERO ALCOHOL ANTICAVITY FRESH MINT
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0194 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) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM BENZOATE (UNII: OJ245FE5EU) PHOSPHORIC ACID (UNII: E4GA8884NN) EUCALYPTOL (UNII: RV6J6604TK) THYMOL (UNII: 3J50XA376E) METHYL SALICYLATE (UNII: LAV5U5022Y) SACCHARIN SODIUM (UNII: SB8ZUX40TY) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) 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:69968-0194-2 27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/25/2012 2 NDC:69968-0194-9 95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/25/2012 3 NDC:69968-0194-5 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/25/2012 4 NDC:69968-0194-1 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/25/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/25/2012 Labeler - Johnson & Johnson Consumer Inc. (118772437)