DETRODERM SOFT GEL HAND AND SKIN ANTISEPTIC- alcohol gel 
DETRO HEALTHCARE KIMYA SANAYI ANONIM 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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DETRODERM SOFT GEL HAND AND SKIN ANTISEPTIC

Drug Facts

Active ingredient

%80 (V/V) Ethanol

Purpose

Antiseptic

Uses

Hygienic and surgical antiseptic of hands and skin. It is used at all health institutions like surgery, intensive care, clinics, dental clinics, laboratory, veterinary, patient care at home.

Warnings

Flammable. Keep out of ignition sources directly.

Do not use

Before reading user manual

After 6 months from cover opening

When using this product

No smoking. must not be contacted with powerful oxidants, alkali metals due to fire and explosion possibility. Keep out of reach of children, food and animal foods. Keep out of ignition sources directly. Do not stock with oxidant and spontaneously combustible materials. Obey instructions existed in user manual.

Stop use and ask a doctor if

*In case of poisoning

*In case of ingestion

*In case of contact with eyes

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For hygienic hand antiseptic, at least 3 ml solution is applied to hand without dilution and hands are rubbed until drying. For surgical hand antiseptic, 5 ml solution is applied to hand.

Other Information

Store containers tightly closed and in a well-ventilated area between 0-30°C and away from direct sunlight.

Do not use after expiry date.

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, glycerin, triethanolamine, essence, deionized water

Questions

You may also report serious side effects to this phone number (+1-XXX-XXX-XXXX)

Mon-Fri 9:00 AM - 5:00 PM

• Wide Effect Spectrum

• Alcohol Based

• Extensive Skin Compatibility

• Usable at Dispenser

Email: international@detrox.com.tr

MADE IN TURKEY

detrox®

Integrated Disinfection Solutions

Producer Name and Address:

Detro Healthcare Kimya Sanayi A.S.

Ataturk mh. Adnan Menderec cd.

No:7 Esenyurt/Istanbul-Turkey

Packaging

IMAGE

DETRODERM SOFT GEL HAND AND SKIN ANTISEPTIC 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79506-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79506-103-015000 mL in 1 CONTAINER; Type 0: Not a Combination Product04/15/2021
2NDC:79506-103-023780 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2021
3NDC:79506-103-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2021
4NDC:79506-103-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2021
5NDC:79506-103-05250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2021
6NDC:79506-103-06100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/15/2021
Labeler - DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI (533133207)
Establishment
NameAddressID/FEIBusiness Operations
DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI533133207manufacture(79506-103)

Revised: 4/2021
Document Id: a92d86fa-7667-4406-8145-d37782bbbe26
Set id: c7cda759-43cb-4b82-b7cc-f97753ceeaa1
Version: 1
Effective Time: 20210420
 
DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI