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 Ingredient:
Ethyl Alcohol 62%

Purpose:
Antimicrobial

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.

Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate, FD&C Blue NO.1, FD&C Red NO.33.

Other Information:
Store below 110 F.

KILLS MORE THAN 99.99% OF COMMON GERMS

image of bottle label

ANTI-BACTERIAL HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53603-1019
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53603-1019-1	29.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/06/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/06/2015

Labeler - BB17, LLC (828378294)