DERMAPROT TRICLOTREX-B- triclosan liquid

DERMAPROT by

Drug Labeling and Warnings

DERMAPROT by is a Prescription medication manufactured, distributed, or labeled by SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS, SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

This product must be keep out of reach of children

INDICATIONS & USAGE

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

WARNINGS

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

DOSAGE & ADMINISTRATION

Spray an hands before rubbing them.

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

IMAGE OF THE LABEL

INGREDIENTS AND APPEARANCE

DERMAPROT  TRICLOTREX-B
triclosan liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66854-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	Business Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS		880172184	manufacture(66854-004) , analysis(66854-004) , label(66854-004) , pack(66854-004)