ANTI-BACTERIAL LEMON DROP 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 GERMS

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 Yellow NO. 5

image of bottle hangtag
ANTI-BACTERIAL LEMON DROP HAND  
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53603-2013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53603-2013-8236.6 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/06/2012
Labeler - BB17, LLC (828378294)

Revised: 10/2012
Document Id: 8d2085df-6ea3-42a9-85b0-5eeaa509d603
Set id: 2d69c72e-81c4-4a83-af42-97af490fa23b
Version: 4
Effective Time: 20121006
 
BB17, LLC