HAND AND SKIN DISINFECTANT

HAND AND SKIN DISINFECTANT by

Drug Labeling and Warnings

HAND AND SKIN DISINFECTANT 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]

HAND AND SKIN DISINFECTANT- benzalkonium chloride solution 
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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HAND AND SKIN DISINFECTANT

0.1% Benzalkonium chloride (v/v)

Antiseptic

Directions

A ready to use product. Apply to the entire surface of your hands and skin. It is recommended to be used in its original packaging as per hygiene rules.

hand and skin sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

For external use only. Flammable, keep away from fire and flame.

Do not use in children less than 2 months of age and on open skin wounds

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

Stop use and ask doctor in case of poisoning and if irritation and redness develops and persists.

Symptoms of Poisoning are dizziness, loss of consciousness, speech disorder.

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

Aqua, Glycerine, Hypericum Perforatum Extract, Glycyrrhiza Glabra Root Extract, Melaleuca Alternifolia Leaf Extract, Phenoxyethanol, Citric acid, Caprylic/Capric Triglyceride, Olea Europaea Fruit Oil, Cetearyl Alcohol, Ceteareth-25, Glyceryl Stearate, Panthenol

Other informatons

Store between 15-30 ºC
Avoid freezing and excessive heat above 40ºC

LABEL

HAND AND SKIN DISINFECTANT 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79781-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETEARETH-25 (UNII: 8FA93U5T67)
GLYCERIN (UNII: PDC6A3C0OX)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79781-201-01	51.5 g in 1 JAR; Type 0: Not a Combination Product	07/23/2020
2	NDC: 79781-201-02	154.5 g in 1 JAR; 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(79781-201)

Revised: 9/2022

Document Id: e8ce403d-f0a6-668e-e053-2a95a90a6272

34390-5

Set id: a9e8a2a9-b65a-0e62-e053-2995a90a6a40

Version: 4

Effective Time: 20220916

 

MOLECULE KORUYUCU SAGLIK U