MedPath

DERMAPROT

DERMAPROT TRICLOTREX-B

Approved
Approval ID

33ff7919-c967-4874-8d16-30afbdfb9352

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 5, 2012

Manufacturers
FDA

SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

DUNS: 880172184

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

TRICLOSAN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66854-004
Application Numberpart333E
Product Classification
M
Marketing Category
C73603
G
Generic Name
TRICLOSAN
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 5, 2012
FDA Product Classification

INGREDIENTS (12)

TRICLOSANActive
Quantity: 0.3 mg in 100 mL
Code: 4NM5039Y5X
Classification: ACTIM
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DIPYRITHIONEInactive
Code: 9L87N86R9A
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHK
Classification: IACT
DIAZOLIDINYL UREAInactive
Code: H5RIZ3MPW4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT

Drug Labeling Information

WARNINGS SECTION

LOINC: 34071-1Updated: 8/5/2012

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/5/2012

Spray an hands before rubbing them.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/5/2012

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

LOINC: 55105-1Updated: 8/5/2012

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

LOINC: 50565-1Updated: 8/5/2012

This product must be keep out of reach of children

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DERMAPROT - FDA Drug Approval Details