Label: ACT RESTORING ANTICAVITY FLUORIDE COOL MINT- sodium fluoride mouthwash
- NDC Code(s): 41167-0981-2, 41167-0981-7
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 20, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
-
Directions
adults and children 6 years of age and older:
- use twice a day after brushing your teeth with a toothpaste
- remove cap
- pour 10 milliliters into cap (10 mL is equal to 2 teaspoonfuls); do not use more than 10 milliliters
- vigorously swish 10 milliliters 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
- use twice a day after brushing your teeth with a toothpaste
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACT RESTORING ANTICAVITY FLUORIDE COOL MINT
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0981 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.09 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE (UNII: SE337SVY37) POLYSORBATE 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) Product Characteristics Color blue Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0981-7 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2006 2 NDC:41167-0981-2 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2006 08/26/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 02/01/2006 Labeler - Chattem, Inc. (003336013) Establishment Name Address ID/FEI Business Operations CHATTEM, INC. 832973031 label(41167-0981) , manufacture(41167-0981) , pack(41167-0981)
