204 Epi-Clenz Instant hand Antiseptic

Epi-Clenz Instant Hand Antiseptic by

Drug Labeling and Warnings

Epi-Clenz Instant Hand Antiseptic by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EPI-CLENZ INSTANT HAND ANTISEPTIC- ethyl alcohol gel 
Medline Industries, Inc.

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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204 Epi-Clenz Instant hand Antiseptic

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 persists 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, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, tocopheryl acetate, triethanolamine, water.

Package/Label Principal Display Panel

Epi-Clenz Instant Hand Antiseptic

NDC: 53329-204-08

PROFESSIONAL

Hand Hygiene

EPI-CLENZ

INSTANT HAND ANTISEPTIC

Latex Free

REF MSC097038

  • 70% v/v Ethyl Alcohol
  • With Added Moisturizers for Soft Feeling Hands

Medline

Vitamin E & Aloe Vera

8 FL OZ (236 mL)

EPI-CLENZ INSTANT HAND ANTISEPTIC 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-204-1244.4 mL in 1 BOTTLE; Type 0: Not a Combination Product09/20/200701/01/2018
2NDC: 53329-204-841000 mL in 1 BAG; Type 0: Not a Combination Product09/20/200701/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/20/200701/01/2018
Labeler - Medline Industries, Inc. (025460908)

Revised: 1/2020
Document Id: 9d5d3cac-601b-299d-e053-2a95a90a9999
Set id: 5a360dc0-3ffe-41b5-a9f4-d96a17fae2d9
Version: 5
Effective Time: 20200130