CLOSE UP Whitening with Mouthwash

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 2.4mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-645

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 FACTS

Active ingredients        

Sodium fluoride (0.24%)

Purpose
Anticavity toothpaste

Use  aids in the 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)

Carton image

CLOSE UP  WHITENING WITH MOUTHWASH
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-645
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
ALCOHOL 
CARBOXYMETHYLCELLULOSE SODIUM 
SACCHARIN SODIUM DIHYDRATE 
MICA 
D&C RED NO. 33 
FD&C RED NO. 40 
TITANIUM DIOXIDE 
Product Characteristics
ColorredScore    
ShapeSize
FlavorCINNAMON (Cinnamint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10237-645-601 TUBE (TUBE) in 1 CARTON
1170 g in 1 TUBE
2NDC:10237-645-401 TUBE (TUBE) in 1 CARTON
2113.4 g in 1 TUBE
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/FEIOperations
Church & Dwight Co., Inc.043690812manufacture

Revised: 06/2012
 
Church & Dwight Co., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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