I D SEPT ANTI BACTERIAL ALCOHOL BASED HAND AND SKIN DISINFECTANT by DTH SAGLIK HIZMETLERI TICARET ANONIM SIRKETI / HARDAL GLOBAL CONSULTING LLC

Drug Details [pdf]

I D SEPT ANTI BACTERIAL ALCOHOL BASED HAND AND SKIN DISINFECTANT- alcohol liquid
DTH SAGLIK HIZMETLERI TICARET 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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Active Ingredient(s)

Ethyl alcohol 70% w/w, 2-Propanol 0.5% w/w

Purpose

Antiseptic

Alcohol-based hand disinfectant

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Do not use

in children less than 2 months of age
on open skin wounds

For external use only. Keep away from children, food, and animal feed. Do not swallow.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Put enough product ( app.3-5 ml) on hands to cover all surfaces. Rub hands together, until hands feel dry. This should take araound 20 seconds. Do not rinse or wipe off the hand sanitizer before it's dry; it may not work as well against germs.

Supervise children under 6 years of age when they use hand sanitizer gel to prevent swallowing alcohol, especially in schools and childcare facilities.

Other information

Do not use other disinfectant and cleaning agents. It should be used in it's orginal packaging. Store between 15-30 C ( 59-86F).Protect from direct sunlight. Avoid freezing and excessive heat above 40C(104F)

Inactive ingredients

Glycerin, Fragrance, Citric acid, Purified water USP

When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Package Label - Principal Display Panel

DTH Saglik Hizmetleri Tic. A.S. Merkez: Incek Mehmetcik Cad. 2654. Sk. No:2 Golbasi-Ankara

T: +90 312 211 05 06 F: +90 312 211 05 00

wwww.dthsaglik.com - www.idkimya.com

I& D sept INTERNATIONAL DISINFECTION

ANTI-BACTERIAL ALCOHOL BASED HAND AND SKIN DISINFECTANT

For External Use Only

KILLS 99,9% of germs without water

KILLS 99,9% VIRUSES & BACTERIA

I&D

I D SEPT ANTI BACTERIAL ALCOHOL BASED HAND AND SKIN DISINFECTANT
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78992-606
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.5 mL in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 78992-606-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78992-606-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 78992-606-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 78992-606-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020	06/29/2020

Labeler - DTH SAGLIK HIZMETLERI TICARET ANONIM SIRKETI (566220129)

Registrant - HARDAL GLOBAL CONSULTING LLC (123584960)

Name	Address	ID/FEI	Business Operations
Establishment
DTH SAGLIK HIZMETLERI TICARET ANONIM SIRKETI		566220129	manufacture(78992-606)

Revised: 6/2020

Document Id: a8da4fd3-e423-836b-e053-2995a90ac8e5

Set id: a8b071e8-144d-e27a-e053-2a95a90ac73f

Version: 2

Effective Time: 20200624

DTH