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 Type HUMAN OTC DRUG Item Code (Source) NDC:41520-225
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER 934 (UNII: Z135WT9208)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-225-15 443 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 02/01/2013
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Business Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(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