Label: CLOSE UP FRESHENING WITH MOUTHWASH- sodium fluoride gel, dentifrice
- NDC Code(s): 10237-644-40, 10237-644-60, 10237-644-72, 10237-644-80
- 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
- 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
CLOSE UP FRESHENING WITH MOUTHWASH
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-644 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) PEG-8 STEARATE (UNII: 2P9L47VI5E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ALCOHOL (UNII: 3K9958V90M) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color RED Score Shape Size Flavor CINNAMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-644-40 1 in 1 CARTON 03/01/2001 1 113.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-644-60 1 in 1 CARTON 03/01/2001 2 170 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:10237-644-72 1 in 1 CARTON 03/01/2001 05/25/2022 3 204 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:10237-644-80 1 in 1 CARTON 03/01/2001 4 226.8 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 03/01/2001 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 MANUFACTURE(10237-644)
