HAND SANITIZER - ethyl alcohol gel 
DZA BRANDS LLC

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

ETHYL ALCOHOL 62%

PURPOSE

ANTIMICROBIAL

USES

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM FIRE.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH THE EYES.  IF CONTACT OCCURS, RINSE WITH WATER.

STOP USING AND ASK A DOCTOR IF

IRRITATION OR RASH DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

PUT ENOUGH PRODUCT IN YOUR PALM TO THROUGHLY COVER YOUR HANDS. RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

OTHER INFORMATION

STORE AT A TEMPERATURE BELOW 110 FAHRENHEIT (43 DEGREES CELCIUS).

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

IMAGE OF HAND SANITIZER

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-268
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)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER 934 (UNII: Z135WT9208)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-268-0259 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/14/2011
Labeler - DZA BRANDS LLC (090322194)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 3/2011
Document Id: ae962ccf-4667-4058-ab89-d393f66a1fa6
Set id: a35720d7-e9ed-459d-a8c4-1c606096afc8
Version: 1
Effective Time: 20110314
 
DZA BRANDS LLC