HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E- ethyl alcohol gel 
DZA BRANDS

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 65 PERCENT

PURPOSE

ANTISEPTIC

USES

TO HELP REDUCE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

WHEN USING THIS PRODUCT

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

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR REDNESS DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.  CHILDREN UNDER 6, SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

OTHER INFORMATION

DO NOT STORE ABOVE 1100F (430C).

QUESTIONS OR COMMENTS

1-866-322-2439

INACTIVE INGREDIENTS

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

FRONT AND BACK LABELS

image of label

HAND SANITIZER  WITH MOISTURIZERS AND VITAMIN E
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-267
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-267-08236 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/12/2011
Labeler - DZA BRANDS (090322194)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 10/2011
Document Id: 7c2a44be-8b78-4d91-9ef0-cc4268d7435f
Set id: 706e7e2c-7b57-406b-adb2-6ce595e69df3
Version: 1
Effective Time: 20111012
 
DZA BRANDS