Label: ACT KIDS ANTICAVITY FLUORIDE GROOVY GRAPE- sodium fluoride paste, dentifrice
- NDC Code(s): 41167-0926-1
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 20, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor children 2 to 6 years of age instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision. children under 2 years of age consult a dentist or doctor - Inactive ingredients
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INGREDIENTS AND APPEARANCE
ACT KIDS ANTICAVITY FLUORIDE GROOVY GRAPE
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0926 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) SUCRALOSE (UNII: 96K6UQ3ZD4) BENZOIC ACID (UNII: 8SKN0B0MIM) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0926-1 130 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 01/01/2021 Labeler - Chattem, Inc. (003336013)