3E CLEAN HAND SANITIZER- alcohol liquid

3e Clean Hand Sanitizer by

Drug Labeling and Warnings

3e Clean Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

USE(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease  For usewhen soap and water are not available.

WARNING

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

DO NOT Use

* in children less than 3 years of age* on open skin wounds

When using this product,

keep out of eyes,ears and mouth. In case of contact with eyes, rinse eyes throughly with water.

Stop use and ask a doctor

if irritation or rash occurs.These may be signs of a serious condition.

Keep out of reach of children.

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

DIRECTIONS

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

INACTIVE INGREDIENTS

Water (Aqua),Glycerin, Carbomer,Parfum, Dmdm Hydantoin, Triethanolamine,Butylphenyl Methylpropional, Coumarin,Benzyl salicylate, Benzyl Alcohol, Linalool.

OTHER INFORMATION

* Store between 5-25C (41-77F) Avoid freezing and excessive heat above 40C (104F).

Package Labeling

INGREDIENTS AND APPEARANCE

3E CLEAN HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78896-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TROLAMINE (UNII: 9O3K93S3TK)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
COUMARIN (UNII: A4VZ22K1WT)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78896-001-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/20/2020

Labeler - Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI. (533147719)

Establishment
Name	Address	ID/FEI	Business Operations
Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI.		533147719	manufacture(78896-001) , label(78896-001) , pack(78896-001) , relabel(78896-001) , repack(78896-001) , transfill(78896-001)