TRICLOTREX-B ANTIBACTERIAL (NEUTRAL)- triclosan gel

TRICLOTREX-B by

Drug Labeling and Warnings

TRICLOTREX-B by is a Otc medication manufactured, distributed, or labeled by SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

PURPOSE

THIS PRODUCT ACT AS A PROTECTOR AGAINST FUNGI AND BACTERIA.

KEEP OUT OF REACH OF CHILDREN

THIS PRODUCT MUST BE KEEP OUT  REACH OF EYES CHILDREN.

INDICATIONS & USAGE

THIS PRODUCT IS FOR TOPICAL APPLICATION,

WARNINGS

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

IMAGE OF THE LABEL

INGREDIENTS AND APPEARANCE

TRICLOTREX-B  ANTIBACTERIAL (NEUTRAL)
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66854-016
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C BLUE NO. 4 (UNII: 0KSY80VYS3)

Product Characteristics
Color	purple (PURPLE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66854-016-01	110 g in 1 JAR
2	NDC: 66854-016-02	430 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	04/16/2012

Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

Establishment
Name	Address	ID/FEI	Business Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS		880172184	analysis, label, manufacture, pack