HAND SANITIZER - ethyl alcohol gel 
HEB

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

ANTIBACTERIAL

USES:

TO DECREASE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ON THE HANDS ONLY.  IN CASE OF ACCIDENTAL INGESTION, SEEK MEDICAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES.  IF EYE CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

IF SKIN IRRITATION DEVELOPS,

DISCONTINUE USE AND CONTACT A DOCTOR.

FOR CHILDREN UNDER 6, USE ONLY WITH ADULT SUPERVISION. NOT RECOMMENDED FOR USE ON INFANTS.

DIRECTIONS:

PUT A SMALL AMOUNT IN YOUR PALM AND BRISKLY RUB HANDS TOGETHER UNTIL DRY.

OTHER INFORMATION

FLAMMABLE.  KEEP AWAY FROM HEAT AND FLAME.

INACTIVE INGREDIENTS

WATER, GLYCERIN, ALUMINA, ISOPROPYL MYRISTATE,  TITANIUM DIOXIDE, BUTYROSPERMUM PARKII (SHEA BUTTER) EXRACT, TOCOPHERYL ACETATE, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE.

IMAGE OF HAND SANITIZER

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-238
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SHEANUT OIL (UNII: O88E196QRF)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-238-0374 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/03/2011
Labeler - HEB (007924756)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 2/2011
Document Id: fb4d941d-3af3-4898-a3de-cf75e7e06b02
Set id: 82df10f3-5a82-4503-871a-13054cb531f2
Version: 1
Effective Time: 20110203
 
HEB