ANTIBACTERIAL SANITIZER- ethyl alcohol liquid 
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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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DRUG FACTS

ACTIVE INGREDIENT

ETHYL ALCOHOL 62%

PURPOSE

ANTIBACTERIAL

USES

TO DECREASE THE 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.

STOP USE AND ASK DOCTOR

IF SKIN IRRITATION DEVELOPS

KEEP OUT OF THE REACH OF CHILDREN

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

DIRECTIONS

SPRAY A SMALL AMOUNT ONTO HANDS AND BRISKLY RUB HANDS TOGETHER UNTIL DRY

OTHER INFORMATION

FLAMMABLE. KEEP AWAY FROM HEAT AND FLAME.

INACTIVE INGREDIENTS

WATER, PROPYLENE GLYCOL, GLYCERIN, FRAGRANCE, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE.

LABEL COPY

image of the label

ANTIBACTERIAL  SANITIZER
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-235
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-235-017.4 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/08/2011
Labeler - H E B (007924756)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 8/2011
Document Id: cbd9e5c4-e22d-4bbc-8bee-60af7e7980c3
Set id: 788c9703-486e-4009-bd69-fbb76d446030
Version: 1
Effective Time: 20110808
 
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