DETROX - DETRODERM HAND AND SKIN ANTISEPTIC- isopropyl alcohol liquid 
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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DETROX DETRODERM HAND AND SKIN ANTISEPTIC

Drug Facts

Active ingredient

%70 Isopropyl Alcohol

Purpose

Antiseptic

Uses

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

1,3-butanediol, glycerin, 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 Compatability

• Usable at Dispenser

Email: international@detrox.com.tr

MADE IN TURKEY

Producer Name and Address:

Detro Healthcare Kimya Sanayi A.S.

Atatürk mh. Adnan Menderes cd. No:7

Esenyurt/Istanbul-Turkey

Packaging

IMAGE

DETROX  - DETRODERM HAND AND SKIN ANTISEPTIC
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79506-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79506-100-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
2NDC:79506-100-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
3NDC:79506-100-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
4NDC:79506-100-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
5NDC:79506-100-055000 mL in 1 CAN; Type 0: Not a Combination Product06/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/30/2020
Labeler - DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI (533133207)
Establishment
NameAddressID/FEIBusiness Operations
DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI533133207manufacture(79506-100)

Revised: 7/2020
Document Id: 22399241-cbbd-4248-b8ba-628fe4101534
Set id: 6c32c72e-efd2-4a99-a279-0f3296b06bea
Version: 1
Effective Time: 20200724
 
DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI