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NDC 79506-0101-05 DETROX 70 mL/100mL Details

DETROX 70 mL/100mL

DETROX is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	79506-0101
Product ID	79506-101_1505a698-a6ca-4a2a-bbf3-f727322f1a1f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DETROX
Proprietary Name Suffix	DETRODERM Gel HAND AND SKIN ANTISEPTIC
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 79506-0101-05 (79506010105)

Pricing Information	N/A
NDC Package Code	79506-101-05
Billing NDC	79506010105
Package	5000 mL in 1 CAN (79506-101-05)
Marketing Start Date	2020-06-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a843c938-3285-4a34-879f-ec23f58055e0 Details

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, carbomer, 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

SPL UNCLASSIFIED SECTION

• Wide Effect Spectrum

• Alcohol Based

• Extensive Skin Compatability

• Usable at Dispenser

Email: [email protected]

MADE IN TURKEY

Producer Name and Address:

Detro Healthcare Kimya Sanayi A.S.

Atatürk mh. Adnan Menderes cd.

No:7 Esenyurt/Istanbul-Turkey

Packaging

INGREDIENTS AND APPEARANCE

DETROX - DETRODERM GEL HAND AND SKIN ANTISEPTIC

isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79506-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79506-101-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
2	NDC:79506-101-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
3	NDC:79506-101-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
4	NDC:79506-101-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
5	NDC:79506-101-05	5000 mL in 1 CAN; Type 0: Not a Combination Product	06/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/30/2020

Labeler - DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI (533133207)

Name	Address	ID/FEI	Business Operations
Establishment
DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI		533133207	manufacture(79506-101)

Revised: 7/2020

Document Id: 1505a698-a6ca-4a2a-bbf3-f727322f1a1f

Set id: a843c938-3285-4a34-879f-ec23f58055e0

Version: 1

Effective Time: 20200724