MedPath
FDA Approval

DERMAPROT

August 5, 2012

HUMAN PRESCRIPTION DRUG LABEL

Triclosan(0.3 mg in 100 mL)

Manufacturing Establishments (1)

SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

880172184

Products (1)

DERMAPROT TRICLOTREX-B

66854-004

part333E

C73603

TOPICAL

August 5, 2012

TriclosanActive
Code: 4NM5039Y5XClass: ACTIMQuantity: 0.3 mg in 100 mL
ALOE VERA LEAFInactive
Code: ZY81Z83H0XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
DIPYRITHIONEInactive
Code: 9L87N86R9AClass: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHKClass: IACT
DIAZOLIDINYL UREAInactive
Code: H5RIZ3MPW4Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT

Drug Labeling Information

DOSAGE & ADMINISTRATION SECTION

Spray an hands before rubbing them.


WARNINGS SECTION

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


OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

This product must be keep out of reach of children


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