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Name:Aim Clinicalmaximum Fluoride Level Without A Prescription
Manufacturer:Church & Dwight Co., Inc.
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

AIM CLINICAL MAXIMUM FLUORIDE LEVEL WITHOUT A PRESCRIPTION - sodium monofluorophosphate 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 Monofluorophosphate (1.15%)

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 do not use unless directed by a dentist or doctor

Inactive ingredients  sorbitol, water, hydrated silica, PEG-32, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, mica, titanium dioxide

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

Principal Display Panel

Aim CLINCIAL
Anticavity Fluoride Toothpaste


MAXIMUM FLUORIDE LEVEL
without a Prescription

NET WT. 3.8 OZ (107g)

Strengthens Enamel    Protects   Cleans    Freshens

Cool Mint Paste

Carton image
Carton image


AIM CLINICAL  MAXIMUM FLUORIDE LEVEL WITHOUT A PRESCRIPTION
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-627
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE 11.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL  
WATER  
HYDRATED SILICA  
PEG-32 STEARATE  
SODIUM LAURYL SULFATE  
ALCOHOL  
CARBOXYMETHYLCELLULOSE SODIUM  
SACCHARIN SODIUM  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score     
Shape Size
Flavor MINT (Cool Mint) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-627-38 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 107 g in 1 TUBE This package is contained within the CARTON (10237-627-38)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 07/01/2010

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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