ANTI-BACTERIAL HAND GEL- ethyl alcohol gel 
Jean Pierre 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 Ingredient: Ethyl Alcohol 62%

Purpose Antiseptic

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: Squeeze as needed into your palms and thoroughly spread on bottom hands. Rub into skin until dry.

Inactive ingredients: Water, Aloe Barbadenis Leaf, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, FD&C Blue No.1

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

Other information

Do not store in temperature over 118 F.

image of bottle label

ANTI-BACTERIAL HAND GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70483-001
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70483-001-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/25/2016
Labeler - Jean Pierre Inc. (138328393)

Revised: 5/2016
Document Id: 33baa936-1833-620b-e054-00144ff88e88
Set id: 33baa936-1832-620b-e054-00144ff88e88
Version: 1
Effective Time: 20160526
 
Jean Pierre Inc.