Label: KIDS KARE- sodium fluoride paste, dentifrice
- NDC Code(s): 59883-718-04
- Packager: DEN-MAT HOLDINGS, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2023
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- Active ingredient
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor.
- Children under 2 years of age: Consult a dentist or doctor.
- Do not swallow.
- To minimize swallowing, use a pea-sized amount in children under 6.
- Instruct children under 6 years of age in good brushing and rinsing habits.
- Supervise children as necessary until capable of using without supervision.
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
KIDS KARE
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59883-718 Route of Administration DENTAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) SORBITOL (UNII: 506T60A25R) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) BERRY (UNII: FV3431923Z) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59883-718-04 113.4 g in 1 TUBE; Type 0: Not a Combination Product 10/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 10/26/2017 Labeler - DEN-MAT HOLDINGS, LLC. (809857704)