TOP CARE BRILLIANT WHITE- sodium fluoride paste, dentifrice 
TOPCO Assoc. LLC

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 / Purpose

Sodium fluoride 0.243% ............Anticavity

Uses

Children under 2 years of age, consult a dentist or doctor

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing). Supervise children as necessary until capable of using without supervision.

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, xanthan gum, carbomer, sodium saccharin, sodium hydroxide, mica, titanium dioxide, blue 1 lake, polyethylene

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Carton label

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Tube Label

TOP CARE  BRILLIANT WHITE
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-285
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.243 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SACCHARIN SODIUM 
SORBITOL 
TITANIUM DIOXIDE 
SODIUM HYDROXIDE 
XANTHAN GUM 
HYDRATED SILICA 
SODIUM ACID PYROPHOSPHATE 
CARBOXYMETHYLCELLULOSE SODIUM 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
SODIUM LAURYL SULFATE 
MICA 
Product Characteristics
Colorblue (light blue with sparkles) Score    
ShapeSize
FlavorMINT (mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-285-591 in 1 CARTON
1NDC:36800-285-52164 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/20/2011
Labeler - TOPCO Assoc. LLC (006935977)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(36800-285), pack(36800-285)

Revised: 11/2012
Document Id: f6fd8623-f4d7-44a8-9003-9c7e2b51d51e
Set id: b5611930-27e4-4918-bf92-a96f20b36b8a
Version: 1
Effective Time: 20121129
 
TOPCO Assoc. LLC