3E CLEAN HAND SANITIZER- alcohol liquid 
Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI.

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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3e Clean Hand Sanitizer

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

Label1

3E CLEAN HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78896-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78896-001-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/20/2020
Labeler - Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI. (533147719)
Establishment
NameAddressID/FEIBusiness Operations
Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI.533147719manufacture(78896-001) , label(78896-001) , pack(78896-001) , relabel(78896-001) , repack(78896-001) , transfill(78896-001)

Revised: 6/2020
Document Id: a86fbe45-08e1-bddf-e053-2a95a90aa792
Set id: eb05f4f0-13ff-4b8b-a71e-d1d8eb4e9d5a
Version: 1
Effective Time: 20200619
 
Erenay Kozmetik Gida Insaat Turizm Tekstil Tasimacilik Sanayi LTD. STI.