Label: ORAJEL PAW PATROL- sodium fluoride paste, dentifrice
- NDC Code(s): 10237-786-42
- 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
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
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 or physician - INACTIVE INGREDIENT
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAJEL PAW PATROL
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-786 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 HYDRATED SILICA (UNII: Y6O7T4G8P9) METHYL SALICYLATE (UNII: LAV5U5022Y) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM LAURYL SULFATE (UNII: 368GB5141J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-786-42 119 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2019 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(10237-786)