DERMAPROT TRICLOTREX-B- triclosan liquid 
SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

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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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 LABELIMAGE OF THE LABEL

DERMAPROT  TRICLOTREX-B
triclosan liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66854-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIPYRITHIONE (UNII: 9L87N86R9A)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66854-004-01500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E08/30/2012
Labeler - SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Establishment
NameAddressID/FEIBusiness Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184manufacture(66854-004) , analysis(66854-004) , label(66854-004) , pack(66854-004)

Revised: 8/2012
Document Id: 232823a8-d199-498c-98b3-15e8ad88ee2f
Set id: 33ff7919-c967-4874-8d16-30afbdfb9352
Version: 1
Effective Time: 20120805
 
SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS