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Epi-Clenz Instant Hand Antiseptic

Dosage form: gel
Ingredients: ALCOHOL 70mL in 100mL
Labeler: Medline Industries, Inc.
NDC Code: 53329-212

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 70% v/v

Purpose

Antiseptic

Uses
  • for handwashing to decrease bacteria on skin.
  • recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do Not Use
  • in the eyes. In case of eye contact, immediately flush with water.

Stop use and ask a doctor if
  • irritation or redness develop
  • Condition persist for more than 72 hours

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • wet hands thoroughly with product
  • rub hands together covering all surfaces until hands are dry.

Inactive Ingredients

Aloe barbadensis leaf juice, Aminomethyl Propanol, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, purified water, Tocopheryl Acetate.

Package/Label Principal Display Panel
EPI-CLENZ INSTANT HAND ANTISEPTIC 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-212
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) 
GLYCERIN 
ISOPROPYL ALCOHOL 
ISOPROPYL MYRISTATE 
PROPYLENE GLYCOL 
.ALPHA.-TOCOPHEROL ACETATE, D- 
WATER 
AMINOMETHYLPROPANOL 
Packaging
#Item CodePackage Description
1NDC:53329-212-04118 mL in 1 BOTTLE
2NDC:53329-212-06473 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/30/2013
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIOperations
Hydrox Laboratories025164302manufacture(53329-212)

Revised: 01/2018
 
Medline Industries, Inc.

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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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