Label: ACT WHITENING ANTICAVITY GENTLE MINT (sodium fluoride 0.02- 0.009 w/v fluoride ion mouthwash
- NDC Code(s): 41167-0983-2
- 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
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Directions
adults and children 12 years of age and older:
■ use twice a day after brushing your teeth with a toothpaste
■ vigorously swish 10 milliliters (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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACT WHITENING ANTICAVITY GENTLE MINT
sodium fluoride 0.02 (0.009 w/v fluoride ion) mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0983 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) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) HYDROGEN PEROXIDE (UNII: BBX060AN9V) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PENTYLENE GLYCOL (UNII: 50C1307PZG) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE (UNII: SE337SVY37) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) 4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C) MENTHOL (UNII: L7T10EIP3A) SUCRALOSE (UNII: 96K6UQ3ZD4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0983-2 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 03/01/2019 Labeler - Chattem, Inc. (003336013)