Label: PEPSODENT COMPLETE CARE ORIGINAL- sodium fluoride paste, dentifrice
- NDC Code(s): 10237-651-55, 10237-651-60
- 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 23, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions 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
- QUESTIONS
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PEPSODENT COMPLETE CARE ORIGINAL
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-651 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ALCOHOL (UNII: 3K9958V90M) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-651-60 1 in 1 CARTON 03/01/2004 10/01/2019 1 170 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-651-55 1 in 1 CARTON 03/01/2004 2 156 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 03/01/2004 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture(10237-651)