Label: LISTERINE TOTAL CARE STAIN REMOVER ANTICAVITY FLUORIDE FRESH MINT- sodium fluoride mouthwash
- NDC Code(s): 69968-0537-1, 69968-0537-3
- Packager: Johnson & Johnson Consumer Inc.
- 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 January 6, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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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
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
ANTICAVITY FLUORIDE MOUTHWASH
LISTERINE ®
TOTAL CARE
STAIN REMOVER
IMPORTANT: READ DIRECTIONS FOR PROPER USE
SODIUM FLUORIDE &
ACIDULATED PHOSPHATE TOPICAL SOLUTION6 IN 1
BENEFITS
1.HELPS PREVENT CAVITIES
2.RESTORES ENAMEL
3.STRENGTHENS TEETH
4.KILLS BAD BREATH GERMS
5.CLEANS THE WHOLE MOUTH
6.FRESHENS BREATHFRESH MINT
946 mL (32 Fl Oz)
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INGREDIENTS AND APPEARANCE
LISTERINE TOTAL CARE STAIN REMOVER ANTICAVITY FLUORIDE FRESH MINT
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0537 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) ALCOHOL (UNII: 3K9958V90M) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLOXAMER 407 (UNII: TUF2IVW3M2) HYDROGEN PEROXIDE (UNII: BBX060AN9V) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0537-1 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2010 2 NDC:69968-0537-3 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2010 09/07/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/01/2010 Labeler - Johnson & Johnson Consumer Inc. (118772437)