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Name:Aimcavity Protection With Whitening
Manufacturer:Church & Dwight Co., Inc.
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

AIM CAVITY PROTECTION WITH WHITENING - 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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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-32, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, mica, titanium dioxide, red 33, red 40

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

Principal Display Panel

TAKE AIM AGAINST CAVITIES

AIM Cavity Protection
With Whitening

CinnaMint Gel

NET WT. 6.0 OZ. (170g) Anticavity Fluoride Gel Toothpaste

MULTI-BENEFIT      Cleans   Freshens   Protects

Carton imageCarton image


AIM  CAVITY PROTECTION WITH WHITENING
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-630
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
SORBITOL  
WATER  
HYDRATED SILICA  
PEG-32 STEARATE  
SODIUM LAURYL SULFATE  
ALCOHOL  
CARBOXYMETHYLCELLULOSE SODIUM  
SACCHARIN SODIUM  
MICA  
TITANIUM DIOXIDE  
D&C RED NO. 33  
FD&C RED NO. 40  
Product Characteristics
Color red Score     
Shape Size
Flavor CINNAMON (Cinnamint) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-630-60 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 170 g in 1 TUBE This package is contained within the CARTON (10237-630-60)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 11/10/2010

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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