ANTI BACTERIAL HAND SANITIZER - ethyl alcohol gel 
Dolgencorp Inc

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
Antiseptic

Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommend for repeated use.

Warnings: For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.

Do not use in ears or mouth.
When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children. Children must be supervised in use of this product.

Directions: Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.                                                                                                                                                                          
Other information: Do not store in temperature over 118 F.  

INACTIVE INGREDIENTS:Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice

image of bottle label
ANTI BACTERIAL HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-988
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-988-0429 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/03/2014
Labeler - Dolgencorp Inc (068331990)

Revised: 9/2014
Document Id: 973793bf-190b-448d-8c16-9fc05358ca08
Set id: c28c59a2-cfdb-4ca5-9a00-9cd76df2a1e6
Version: 1
Effective Time: 20140903
 
Dolgencorp Inc