INSTANT HAND SANITIZER LEMON DROP  - 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% 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 Yellow NO.5

image of bottle hangtag
INSTANT HAND SANITIZER LEMON DROP  
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53603-2003
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 62 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53603-2003-8 236.6 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 12/06/2012
Labeler - BB17, LLC (828378294)

Revised: 12/2012
Document Id: e2be66b2-ba2f-4861-97b4-45dab38c4743
Set id: d1b67c9f-390a-4481-ac98-c35ef1298047
Version: 3
Effective Time: 20121206
 
BB17, LLC