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HAND SANITIZER by DZA BRANDS LLC

Dosage form: gel
Ingredients: ALCOHOL 62mL in 100mL
Labeler: DZA BRANDS LLC
NDC Code: 55316-223

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.

DRUG FACTS

ACTIVE INGREDIENT

ETHYL ALCOHOL 65%

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 IMMEDIATELY.

DIRECTIONS

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

OTHER INFORMATION

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

QUESTIONS AND COMMENTS

1-866-322-2439

INACTIVE INGREDIENTS

WATER, GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, CARBOMER, FRAGRANCE, ALOE BARBADENSIS LEAF JUICE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-223
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 
CARBOMER 934 
AMINOMETHYLPROPANOL 
PROPYLENE GLYCOL 
ALPHA-TOCOPHEROL ACETATE 
ALOE VERA LEAF 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:55316-223-08236 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/23/2011
Labeler - DZA BRANDS LLC (090322194)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 06/2011
 
DZA BRANDS LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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