SKIN AND HAND DISNFECTANT by MOLECULE KORUYUCU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI

SKIN AND HAND DISNFECTANT by

Drug Labeling and Warnings

SKIN AND HAND DISNFECTANT by is a Otc medication manufactured, distributed, or labeled by MOLECULE KORUYUCU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKIN AND HAND DISNFECTANT- alcohol liquid 
MOLECULE KORUYUCU SAGLIK URUNLERI SANAYI VE 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 Ingradient

Alcohol 84% (v/v)

Purpose

Antiseptic

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

A ready-to-use solution for hands and skin. Apply 3-5 ml to the palm of your hand, spread over your hand and skin. Repeat the process according to the hygiene situation. It is recommended to be used and stored in its original package.

Warnings

For external use only. Do not bring in contact with an unhealed wound. Flammable, keep away from fire and flame.

Do not use

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

When using this product

Avoid contact with eyes: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
In case of swallowing the product: Rinse your mouth immediately. Help the person drink water. Do not cause to vomit. Seek an emergency medical care immediately.
In case of inhaling the product: There is no expected symptom. If any unexpected result occurs, seek medical advice during contact with the skin, seek medical advice.

Stop use and ask doctor

If irritation and redness develops and persists. In case of poisoning: Call the National Emergency Services immediately.Symptoms of Poisoning: Dizziness, loss of consciousness, speech disorder.

Keep out of reach of children

If swallowed, contact a doctor or Poison Control Center right away.

Inactive Ingradients

Glycerin, Hypericum Perforatum Oil, Melaleuca alternifolia leaf oil, Aqua

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

LABEL

SKIN AND HAND DISNFECTANT 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79781-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	84 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79781-203-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/23/2020	09/20/2020

Labeler - MOLECULE KORUYUCU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (533147775)

Establishment
Name	Address	ID/FEI	Business Operations
MOLECULE KORUYUCU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI		533147775	manufacture(79781-203)

Revised: 9/2022

Document Id: e8ce0920-8589-b853-e053-2a95a90aba4d

34390-5

Set id: a9e8564a-a17d-6a5d-e053-2995a90a78ba

Version: 2

Effective Time: 20220916

 

MOLECULE KORUYUCU SAGLIK U