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

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 Sanitizer

Active ingredient

Ethyl Alcohol 70% v/v

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

53329-204

EPI-CLENZ INSTANT HAND ANTISEPTIC
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-204
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-204-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2007	11/27/2018
2	NDC:53329-204-06	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2007	01/31/2022
3	NDC:53329-204-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2007	01/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/20/2007	01/31/2022

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

Revised: 11/2021

Document Id: d1000de9-822c-5f51-e053-2995a90a8070

Set id: f740b771-4175-4434-99fd-de0c12f19794

Version: 9

Effective Time: 20211117

Medline Industries, LP