Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
- NDC Code(s): 11344-163-86
- Packager: Consumer Product Partners, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 26, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Use
- WARNINGS
- Keep out of the 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 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 - Store
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Adverse reactions
-
Principal display panel
Sealed With Printed Neckband For Your Protection
Swan
ANTICAVITY
Fluoride
Rinse
SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION
eucalyptus mint
- Restores Enamel
- Freshens Breath
- Helps Prevent Cavities
- Helps Strengthen Teeth
- Helps Kill Germs That Cause Bad Breath
Compare to the active ingredient of Listerine Total Care Fresh Mint Anticavity Mouthwash
IMPORTANT: READ DIRECTIONS FOR PROPER USE
1 LITER (33.8 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11344-163 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) POLOXAMER 407 (UNII: TUF2IVW3M2) EUCALYPTOL (UNII: RV6J6604TK) METHYL SALICYLATE (UNII: LAV5U5022Y) MENTHOL (UNII: L7T10EIP3A) PHOSPHORIC ACID (UNII: E4GA8884NN) SACCHARIN (UNII: FST467XS7D) THYMOL (UNII: 3J50XA376E) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) 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:11344-163-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/13/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 05/13/2006 Labeler - Consumer Product Partners, LLC (119091520) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(11344-163)