EPI-CLENZ INSTANT HAND ANTISEPTIC- ehtyl alcohol gel
Hydrox Laboratories

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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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

PROFESSIONAL
Hand Hygiene
EPI-CLENZ
INSTANT HAND ANTISEPTIC
Latex Free
REF MSC097033
70% v/v Ethyl Alcohol
With Added Moisturizers for Soft Feeling Hands
Medline
Vitamin E & Aloe Vera
16 FL OZ (473 mL)

image description

EPI-CLENZ INSTANT HAND ANTISEPTIC
ehtyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10565-461
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 934 (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:10565-461-04	118 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/22/2017	12/27/2018
2	NDC:10565-461-08	237 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/22/2017	12/27/2018
3	NDC:10565-461-16	473 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/22/2017	12/27/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/22/2017	12/27/2018

Labeler - Hydrox Laboratories (025164302)

Name	Address	ID/FEI	Business Operations
Establishment
Hydrox Laboratories		025164302	manufacture(10565-461) , label(10565-461)

Revised: 12/2018

Document Id: f5619e82-f5b4-4825-a59e-577ba7d2f405

Set id: 29d97ea8-224a-45f7-9ec0-6ddee2bbd58e

Version: 2

Effective Time: 20181228

Hydrox Laboratories