Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
- NDC Code(s): 36800-213-44
- Packager: Topco Associates, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 3, 2025
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- Official Label (Printer Friendly)
- Tamper Evident Statement
- Active ingredient
- Purpose
- Use
- Warning
- Keep out of reach of children.
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Directions
- adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.
- remove cap
- pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
- vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
- do now 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
- Other information
- Inactive ingredients
- Questions?
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Adverse reactions
*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ®Anticavity Fluoride Mouthwash.
DISTRIBUTED BY: TOCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
(C) TOPCO VIJ717 QUESTIONS? 1-888-423-0139
topcare@topcare.com www.topcarebrand.com
QUALITY GUARANTEED
This Top Care product is laboratory tested to guarantee its highest quality.
Your total satisfaction is guaranteed.
- Principal display panel
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INGREDIENTS AND APPEARANCE
ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-213 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) MENTHOL (UNII: L7T10EIP3A) METHYL SALICYLATE (UNII: LAV5U5022Y) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PHOSPHATE (UNII: SE337SVY37) SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BENZYL ALCOHOL (UNII: LKG8494WBH) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-213-44 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/20/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 10/20/2003 Labeler - Topco Associates, LLC (006935977) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(36800-213)
