ANTI-BACTERIAL 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 OR PHYSICIAN.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS:

Rub into hands 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 Yellow NO.5

ANTI-BACTERIAL HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53603-1015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53603-1015-1	29.5 mL in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/26/2014

Labeler - BB17, LLC (828378294)