ANTI-BACTERIAL BUBBLE GUM HAND  - triclosan soap 
BB17, LLC

Disclaimer: 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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:53603-2014
Route of Administration TOPICAL DEA Schedule     
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)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53603-2014-8 236.6 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 11/30/2012
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