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TRICLOTREX-B ANTIBACTERIAL

Dosage form: gel
Ingredients: TRICLOSAN 0.3g in 100g
Labeler: SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
NDC Code: 66854-015

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.

TRICLOTREX-B ANTIBACTERIAL GEL

THIS PRODUCT IS AN ANTIBACTERIAL GEL WHICH PRODUCES A SYNERGISTIC EFFECT BETWEEN THE TRICLOSAN IS THE ACTIVE INGREDIENT WITH A VOLATILE CARRIER SUCH AS ALCOHOL.

THIS PRODUCT ACT AS A PROTECTOR AGAINST FUNGI AND BACTERIA.

THIS PRODUCT MUST BE KEEP OUT  REACH OF EYES CHILDREN.

THIS PRODUCT IS FOR TOPICAL APPLICATION,

IF THIS PRODUCT TO CONTACT WITH EYES RINSE IMMEDIATELY WITH WATER AND CONSULT YOUR DOCTOR

APPLY A MODERATE AMOUNT OF TRICLOTREX GEL ON THE PALM OF YOUR HAND AND RUB SPREADING IT EVENLY OVER BOTH HANDS.

TRICLOSAN, CETIOL AND ALOE VERA EXTRACTS BUILT A PROTECTIVE GLOVE FOR YOUR HANDS PREVENTING THE CONTAMINATION CAUSED BY FUNGI AND BACTERIA

IMAGE OF THE LABEL




TRICLOTREX-B  ANTIBACTERIAL
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
WATER 
PROPYLENE GLYCOL 
PEG-7 GLYCERYL COCOATE 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
ALOE VERA LEAF 
TROLAMINE 
EXT. D&C VIOLET NO. 2 
FD&C YELLOW NO. 5 
FD&C RED NO. 40 
D&C BLUE NO. 4 
Product Characteristics
Colorpurple (PURPLE) , pink (PINK) , green (GREEN) , white (CLEAR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:66854-015-01110 g in 1 JAR
2NDC:66854-015-02430 g in 1 JAR
3NDC:66854-015-03433 g in 1 JAR
4NDC:66854-015-04100 g in 1 JAR
5NDC:66854-015-0620 BAG (BAG) in 1 BOX
5NDC:66854-015-0512 g in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E04/16/2012
Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Establishment
NameAddressID/FEIOperations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack

Revised: 07/2012
 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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