DERMOKIL- hand sanitizer gel gel

Dermokil by

Drug Labeling and Warnings

Dermokil by is a Otc medication manufactured, distributed, or labeled by Halshe, LLC, EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 71.5% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

Do not use on damaged, inflamed or broken skin

When using this product

Avoid contact with eyes

In case of eye contact, rinse eyes thoroughly with water

Stop use

Stop use and ask a doctor if irritation or redness develops and lasts for more than 72 hours.

Keep out of reach of children

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

- allow to dry without wiping

Other information

Other information

- keep out of direct sunlight

- store in dry conditions

Inactive ingredients

glycerin, isopropyl alcohol, sodium hydroxide, purified water USP

Use

Use for hand sanitizing to decrease bacteria on the skin

Package Label - Principal Display Panel

500 ml NDC: 75004-786-55

INGREDIENTS AND APPEARANCE

DERMOKIL 
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75004-786
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	71.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.01 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	2 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75004-786-55	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020

Labeler - Halshe, LLC (114395503)

Registrant - Halshe, LLC (114395503)

Establishment
Name	Address	ID/FEI	Business Operations
EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş.		566224588	manufacture(75004-786)