Label: ORAJEL PAW PATROL- sodium fluoride paste, dentifrice
- NDC Code(s): 10237-795-42
- Packager: Church & Dwight Co., 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.
Drug Label Information
Updated January 10, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- Keep out of reach of children
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Directions
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?
- 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:10237-795 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) Product Characteristics Color Score Shape Size Flavor BERRY (Bubble Berry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-795-42 1 in 1 BOX 10/01/2020 1 119 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 10/01/2020 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 MANUFACTURE(10237-795)
