ANTISEPTIC HAND SANITIZER - alcohol gel 
Innovation Specialties

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.

----------

Drug Facts


Active Ingredient

Ethyl Alcohol 62%


Purpose

Antiseptic

Warnings: Flammable, keep away from fire or flame. For external use only on hands.

When using this product: Avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor: If redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children: If swallowed get medical help or contact a Poison Control Center right away.

Directions: Spread on both hands, rub in, let dry.

Inactive Ingredients: Aloe barbadensis gel, carbomer, fragrance, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water.

Manufactured in China for Innovation Specialties, Culver City, CA 90230 -Questions? Call 1-855-755-5346 - Lot #

Bottle1

Uses: For handwashing to decrease bacteria on the skin.

ANTISEPTIC HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL36.58 mL  in 59 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76138-001-0159 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/27/2011
Labeler - Innovation Specialties (030837314)

Revised: 3/2011
Document Id: 1b91ac3e-2ded-413a-8293-0e1a1101ed36
Set id: 77668c10-a6d7-4a80-8806-0a077013223e
Version: 1
Effective Time: 20110327
 
Innovation Specialties