ANTI-BACTERIAL FRESH ALOE HAND- triclosan soap

Anti-bacterial Fresh Aloe Hand by

Drug Labeling and Warnings

Anti-bacterial Fresh Aloe Hand by is a Otc medication manufactured, distributed, or labeled by BB17, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient:

Triclosan 0.3%

PURPOSE

Purpose
Antimicrobial

INDICATIONS & USAGE

KILLS MORE THAN 99.99% OF COMMON GERMS

WARNINGS

FOR EXTERNAL USE ONLY. 

DO NOT USE IN THE EYES.

STOP USE

DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP. 

IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. 

CHILDREN CAN ONLY USE THIS PRODUCT WITH ADULT SUPERVISION.

DOSAGE & ADMINISTRATION

DIRECTIONS:

WET HANDS.APPLY PALMFUL TO HANDS. SCRUB THOROUGHLY.  

RINISE. RECOMMENDED FOR REPEATED USE.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:Water, Sodium Alkyl Ether Sulphate, Ammonium Lauryl Sulphate, Cocamidopropyl Betaine, Cocamide DEA, Disodium Laureth Sulfosuccinate, Sodium Chloride, Glycol Distearate, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Citric Acid, Disodium EDTA, FD&C Yellow NO. 5, FD&C Blue NO. 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI-BACTERIAL FRESH ALOE HAND  
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53603-2015
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C12-15 PARETH-3 SULFATE (UNII: 19Q4RW8UWP)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53603-2015-8	236.6 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/20/2013

Labeler - BB17, LLC (828378294)