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Name:Age Defyingfluoride And Liquid Calcium
Manufacturer:Church & Dwight Co., Inc.
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

AGE DEFYING FLUORIDE AND LIQUID CALCIUM - sodium fluoride paste, 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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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    supervise children as necessary until capable of using without supervision
                   do not swallow

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   sodium bicarbonate (baking soda), glycerin, PEG-8, hydrated silica, silica, PEG/PPG-116/66 copolymer, calcium sulfate, sodium lauryl sulfate, flavor, dipotassium phosphate, sodium carbonate, sodium saccharin, cellulose gum, titanium dioxide

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

Principal Display Panel

ARM AND HAMMER The Standard of Purity
Fluoride Anti-Cavity Toothpaste

Protects and Rebuilds Enamel   Mint

AGE DEFYING

NET WT. 4.3 OZ. (121g)

Carton imageCarton image


AGE DEFYING  FLUORIDE AND LIQUID CALCIUM
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-601
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.4 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE  
GLYCERIN  
POLYETHYLENE GLYCOL 400  
HYDRATED SILICA  
SILICON DIOXIDE  
POLOXALENE  
CALCIUM SULFATE  
SODIUM LAURYL SULFATE  
PHOSPHATE ION  
SODIUM CARBONATE  
SACCHARIN SODIUM  
CARBOXYMETHYLCELLULOSE SODIUM  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-601-43 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 121 g in 1 TUBE This package is contained within the CARTON (10237-601-43)
2 NDC:10237-601-60 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
2 170 g in 1 TUBE This package is contained within the CARTON (10237-601-60)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 08/01/2007

Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
Name Address ID/FEI Operations
Church & Dwight Co., Inc. 043690812 manufacture

Revised: 11/2010 Church & Dwight Co., Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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