INSTANT HAND SANITIZER - alcohol gel 
AMERICAN SALES COMPANY

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%

USES

TO HELP REDUCE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

  • IRRITATION OR RASH DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

OTHER INFORMATION

DO NOT STORE ABOVE 110OC (43 OC). MAY DISCOLOR CERTAIN FABRICS OR SURFACES.

PURPOSE

ANTISEPTIC

INACTIVE INGREDIENTS

WATER, GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, CARBOMER, FRAGRANCE.

IMAGE OF THE LABEL

INSTANT HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-225
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
ISOPROPYL MYRISTATE 
PROPYLENE GLYCOL 
.ALPHA.-TOCOPHEROL ACETATE, D- 
AMINOMETHYLPROPANOL 
CARBOMER 934 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-225-15443 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/01/2013
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41520-225)

Revised: 2/2013
Document Id: 99db10f5-33ec-4b42-a450-7764118a8a3a
Set id: 01c98735-646b-459f-b541-fcc75b824b29
Version: 2
Effective Time: 20130201
 
AMERICAN SALES COMPANY