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CLOSE UP Freshening with Mouthwash

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 2.4mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-644

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, red 33, red 40.

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

Principal Display Panel                                    Anticavity Fluoride Toothpaste

                                        CLOSE UP
with Ultra
Cinnamon
Flavor Blast

                                                        Cleans, Whitens and Freshens

NET WT. 6.0 OZ. (170g)     FRESHENING GEL    with Mouthwash

Carton image
CLOSE UP  FRESHENING WITH MOUTHWASH
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-644
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 
PEG-8 STEARATE 
SODIUM LAURYL SULFATE 
ALCOHOL 
CARBOXYMETHYLCELLULOSE SODIUM 
SACCHARIN SODIUM DIHYDRATE 
D&C RED NO. 33 
FD&C RED NO. 40 
Product Characteristics
ColorredScore    
ShapeSize
FlavorCINNAMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10237-644-401 TUBE (TUBE) in 1 CARTON
1113.4 g in 1 TUBE
2NDC:10237-644-601 TUBE (TUBE) in 1 CARTON
2170 g in 1 TUBE
3NDC:10237-644-721 TUBE (TUBE) in 1 CARTON
3204 g in 1 TUBE
4NDC:10237-644-801 TUBE (TUBE) in 1 CARTON
4226.8 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/01/2001
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.043690812manufacture

 
Church & Dwight Co., Inc.

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Medically reviewed on Jun 11, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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