Label: ORAJEL KIDSTOOTHPASTE- sodium fluoride paste, dentifrice
- NDC Code(s): 10237-785-42
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 10, 2023
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- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- twist off cap and remove foil seal
- do not swallow
- supervise children as necessary until capable of using without supervision
Adults and children 2 years and older
- brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
Children under 6 years
- Instruct in good brushing and rinsing habits (to minimize swallowing)
Children under 2 years
- ask a dentist of physician
- Inactive ingredients
- Questions or comments?
- Warnings
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ORAJEL KIDSTOOTHPASTE
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-785 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHYL SALICYLATE (UNII: LAV5U5022Y) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-785-42 119 g in 1 TUBE; Type 0: Not a Combination Product 01/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 11/01/2019 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 MANUFACTURE(10237-785)