DR.CLINIC ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel 
MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI

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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dr.Clinic® ANTIBACTERIAL HAND GEL

Drug Facts

Active ingredient

Ethyl alcohol 73%

Purpose

Antibacterial

Uses

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

• in children less than 2 months of age

• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and 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

Other information

Inactive ingredients

carbomer, glycerin, triethanolamine, water

Question? +1-XXX-XXX-XXXX

You may also report serious side effects to this number.

Mon-Fri 9.00 AM - 5.00 PM

MADE IN TURKEY

Name and address of the owner of the manufacturer

/ Name and address of the license holder:

MAKYAJ KOZMETIK IN‑AAT SANAYI TICARET LIMITED ‑IRKETI

Hadımköy Baglantı Yolu Akçaburgaz Mah. Esenyurt / Istanbul

info@makyajkozmetik.com.tr

Packaging

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DR.CLINIC ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76725-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76725-101-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
2NDC:76725-101-06250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
3NDC:76725-101-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
4NDC:76725-101-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
5NDC:76725-101-055000 mL in 1 CAN; Type 0: Not a Combination Product07/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/05/2020
Labeler - MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI (504546402)
Establishment
NameAddressID/FEIBusiness Operations
MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI504546402manufacture(76725-101)

Revised: 7/2020
Document Id: 46c03834-c4d2-4032-823b-e4d93da7dbcf
Set id: 00deac3a-80b8-4b47-98ed-0b401b5cfc0f
Version: 5
Effective Time: 20200730
 
MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI