SIMPLY CLEAN INSTANT HAND SANITIZER  - ethyl alcohol gel 
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 Ingredients
Ethyl Alcohol 62%

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:

Inactive Ingredients: Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate

image of bottle label
SIMPLY CLEAN INSTANT HAND SANITIZER  
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53603-1009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53603-1009-244.3 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/25/2014
Labeler - BB17, LLC (828378294)

Revised: 11/2014
Document Id: c91f4d44-0e19-4551-8460-94fc6d617d08
Set id: 9f019f2f-af57-45c9-8631-aeade139fb35
Version: 2
Effective Time: 20141125
 
BB17, LLC