Your browser does not support JavaScript! INSTANT HAND SANITIZER CANDY APPLE (ETHYL ALCOHOL) GEL [BB17, LLC]
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INSTANT HAND SANITIZER CANDY APPLE (ethyl alcohol) gel
[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 ingredients
Ethyl Alcohol 62% v/v

Purpose
Antimicrobial

KILLS MORE THAN 99.99% OF COMMON GERMS

WARNING:
Flammable, Keep away from fire or flame.  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.

DIRECTIONS:
Rub into skin until dry.
Other Information:
Store below 110 F.

INACTIVE INGREDIENTS:Water, Aloe barbadenis, Leaf Juice, Glycerin,

Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate, FD&C Red NO.33

image of bottle hangtag
INSTANT HAND SANITIZER CANDY APPLE  
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53603-1002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (Alcohol) Alcohol62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALOE 
ALOE VERA LEAF 
GLYCERIN 
PROPYLENE GLYCOL 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
TROLAMINE 
.ALPHA.-TOCOPHEROL ACETATE 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:53603-1002-259.1 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/06/2012
Labeler - BB17, LLC (828378294)

Revised: 12/2012
Document Id: 28c3f21d-0e80-4600-ac64-52b875d14261
Set id: 6904e871-ba91-4aa1-8879-212677c06461
Version: 3
Effective Time: 20121206
 
BB17, LLC

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