Label: ACT KIDS ANTICAVITY FLUORIDE BUBBLE GUM BLOWOUT- sodium fluoride paste
- NDC Code(s): 41167-0922-2, 41167-0922-4
- 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
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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.
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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 as necessary and use a pea-sized amount until your child is capable of using without supervision.
- children under 2 years of age: do not use unless directed by a dentist or doctor
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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.
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACT KIDS ANTICAVITY FLUORIDE BUBBLE GUM BLOWOUT
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0922 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V) 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) Product Characteristics Color pink Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0922-2 130 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2016 2 NDC:41167-0922-4 11 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 11/01/2016 Labeler - Chattem, Inc. (003336013)