CLOSE UP  WHITENING WITH MOUTHWASH- sodium fluoride gel, dentifrice 
Church & Dwight Co., Inc.

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.

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CLOSE UP Whitening Gel

Active ingredients        

Sodium fluoride (0.24%)

Purpose
Anticavity toothpaste

Use

Aids in prevention of dental decay

Warnings
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.

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 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 dioxide

Questions or comments?  Call 1-800-786-5135 Monday-Friday 9am-5pm ET

ANTICAVITY FLUORIDE TOOTHPASTE















CLOSE UP

with







Ultra Cinnamon







Flavor Blast
















Cleans, Whitens and Freshens







with Mouthwash















WHITENING Gel













NET WT. 4.0 OZ. (113.4g)

CUFC-11010-08

CLOSE UP   WHITENING WITH MOUTHWASH
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-645
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
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)  
MICA (UNII: V8A1AW0880)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCINNAMON (Cinnamint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-645-601 in 1 CARTON10/26/201012/18/2021
1170 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10237-645-401 in 1 CARTON10/26/2010
2113.4 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:10237-645-481 in 1 CARTON10/26/2010
3136 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35510/26/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812MANUFACTURE(10237-645)

Revised: 1/2023
Document Id: 81fe3249-dd7c-40e6-9561-e8a76f51f192
Set id: ef70424c-d75c-49f9-8161-3cc5af7b0f13
Version: 9
Effective Time: 20230110
 
Church & Dwight Co., Inc.