Label: ACT ANTICAVITY FLUORIDE KIDS WILD WATERMELON (sodium fluoride 0.24- 0.14 w/v fluoride ion paste
- NDC Code(s): 41167-0924-2
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated May 21, 2019
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- SPL UNCLASSIFIED SECTION
- Active ingredient
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 do not use unless directed by a dentist or doctor
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ACT ANTICAVITY FLUORIDE KIDS WILD WATERMELON
sodium fluoride 0.24 (0.14 w/v fluoride ion) paste
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0924 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) 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) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0924-2 130 g in 1 TUBE; Type 0: Not a Combination Product 05/21/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 05/21/2019 Labeler - Chattem, Inc. (003336013)