Label: CLOSE UP WHITENING WITH MOUTHWASH- sodium fluoride gel, dentifrice
- NDC Code(s): 10237-645-40, 10237-645-60
- 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.
Updated June 12, 2012
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- ACTIVE INGREDIENT
Sodium fluoride (0.24%)
- INDICATIONS & USAGE
Use aids in the prevention of dental decay
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children under 6 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.Close
- DOSAGE & ADMINISTRATION
Directions do not swallow supervise children as necessary until capable of using without supervisionClose
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
Inactive ingredients sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, mica, red 33, red 40, titanium dioxideClose
Questions or comments? Call 1-800-786-5135 Monday-Friday 9am-5pm ETClose
- PRINCIPAL DISPLAY PANEL
ANTICAVITY FLUORIDE TOOTHPASTE
Cleans, Whitens and Freshens
NET WT. 4.0 OZ. (113.4g)
- INGREDIENTS AND APPEARANCE
CLOSE UP WHITENING WITH MOUTHWASH
sodium fluoride gel, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-645 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 (UNII: K679OBS311) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) MICA (UNII: V8A1AW0880) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score Shape Size Flavor CINNAMON (Cinnamint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-645-60 1 in 1 CARTON 1 170 g in 1 TUBE 2 NDC:10237-645-40 1 in 1 CARTON 2 113.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/26/2010 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture