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Dermaprot Triclotrex-B

Generic Name: triclosan
Dosage Form: topical liquid

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.

Dermaprot Triclotrex-B

This product is an antibacterial liquid which produces a synergistic effect between the Triclosan is the active ingredient with a volatile carrier such as alcohol.

This product is designed to produce an antibacterial effect both in the hands and utensils commonly used as combs and scissors in the facial aesthetics

This product must be keep out of reach of children

This product is for topical application as well as being used in beauty salons utensils that need to be desinfected before being used.

If this product to contact with eyes rinse immediately with water and consult a physician.

Spray an hands before rubbing them.

The active ingredient is in a volatile carrier of alcohol, Aloe Vera extract and glycerin to help form a protective glove on the skin and objects that are using this product.

IMAGE OF THE LABEL

DERMAPROT  TRICLOTREX-B
triclosan liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66854-004
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 0.3 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL  
WATER  
GLYCERIN  
ALOE VERA LEAF  
POLYSORBATE 20  
METHYLPARABEN SODIUM  
CITRIC ACID MONOHYDRATE  
DIAZOLIDINYL UREA  
DIPYRITHIONE  
FD&C YELLOW NO. 5  
FD&C BLUE NO. 1  
Product Characteristics
Color green Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:66854-004-01 500 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333E 08/30/2012
Labeler - SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Establishment
Name Address ID/FEI Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS 880172184 manufacture(66854-004), analysis(66854-004), label(66854-004), pack(66854-004)
Revised: 08/2012
 
SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS



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