Your browser does not support JavaScript! ANTI-BACTERIAL BUBBLE GUM HAND (TRICLOSAN) SOAP [BB17, LLC]
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ANTI-BACTERIAL BUBBLE GUM HAND (triclosan) soap
[BB17, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient:
Triclosan 0.3%

Purpose
Antimicrobial

KILLS MORE THAN 99.99% OF COMMON GEMS

FOR EXTERNAL USE ONLY. DO NOT USE IN THE EYES.

DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP. IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR.

Keep out of reach of children. CHILDREN CAN ONLY USE THIS PRODUCT WITH ADULT SUPERVISION.

DIRECTIONS:
WET HANDS.APPLY PALMFUL TO HANDS. SCRUB THOROUGHLY. RINISE. RECOMMENDED FOR REPEATED USE.

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 Red NO. 33

image of bottle hangtag
ANTI-BACTERIAL BUBBLE GUM HAND  
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53603-2014
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM C12-15 PARETH-3 SULFATE 
AMMONIUM LAURYL SULFATE 
COCAMIDOPROPYL BETAINE 
COCO DIETHANOLAMIDE 
DISODIUM LAURETH SULFOSUCCINATE 
SODIUM CHLORIDE 
GLYCOL DISTEARATE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:53603-2014-8236.6 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/30/2012
Labeler - BB17, LLC (828378294)

Revised: 11/2012
Document Id: ddf2a5b8-a5dc-4a5b-84a5-f9345bfa8e22
Set id: 41761f06-df9b-455d-a095-c9305b21d4aa
Version: 1
Effective Time: 20121130
 
BB17, LLC

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