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NDC 79506-0102-02 DETRODERM SOFT HAND AND SKIN ANTISEPTIC 80 mL/100mL Details

DETRODERM SOFT HAND AND SKIN ANTISEPTIC 80 mL/100mL

DETRODERM SOFT HAND AND SKIN ANTISEPTIC is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI. The primary component is ALCOHOL.

Product Information

NDC	79506-0102
Product ID	79506-102_97f4cb01-1c90-484a-8c81-8b630412c345
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	DETRODERM SOFT HAND AND SKIN ANTISEPTIC
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	80
Active Ingredient Units	mL/100mL
Substance Name	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 79506-0102-02 (79506010202)

Pricing Information	N/A
NDC Package Code	79506-102-02
Billing NDC	79506010202
Package	3780 mL in 1 BOTTLE (79506-102-02)
Marketing Start Date	2021-04-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b0001f11-7f9c-431e-aeaa-98fdc6c0cd5f Details

Drug Facts

Active ingredient

%80 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

Glycerin, citric acid monohydrate, 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

SPL UNCLASSIFIED SECTION

• Wide Effect Spectrum

• Alcohol Based

• Extensive Skin Compatibility

• Usable at Dispenser

Email: [email protected]

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

INGREDIENTS AND APPEARANCE

DETRODERM SOFT HAND AND SKIN ANTISEPTIC

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79506-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79506-102-01	5000 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/15/2021
2	NDC:79506-102-02	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2021
3	NDC:79506-102-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2021
4	NDC:79506-102-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2021
5	NDC:79506-102-05	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2021
6	NDC:79506-102-06	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/15/2021

Labeler - DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI (533133207)

Name	Address	ID/FEI	Business Operations
Establishment
DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI		533133207	manufacture(79506-102)

Revised: 4/2021

Document Id: 97f4cb01-1c90-484a-8c81-8b630412c345

Set id: b0001f11-7f9c-431e-aeaa-98fdc6c0cd5f

Version: 1

Effective Time: 20210419