HAND AND SKIN DISINFECTANT SPRAY

Hand and Skin Sanitizer by

Drug Labeling and Warnings

Hand and Skin Sanitizer 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 SANITIZER- alcohol spray 
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 SPRAY

70% Alcohol Denat, 0.1% Benzalkonium Chloride

Antiseptic

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

Directions

Apply to the entire surface of your hands. It is recommended to be used in its original packaging as per hygiene rules

For external use only. Flammable. Keep away from heat or flame

■ on children less than 2 months of age

■ on open skin wounds

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water. keep warm and rest the patient.

If breathing is irregular or stops, give artificial respiration. If unconscious, place in a healing position and seek medical attention immediately. Do not give anything by mouth.
If swallowed: DO NOT vomit. Rinse your mouth with water. Never give anything by mouth to an unconscious patient. Get medical attention immediately.
In case of skin contact: Avoid prolonged contact. Get medical attention if symptoms persist. Remove contaminated clothing and shoes and isolate them. Frozen clothes on the skin must be thawed before removing them. In contact with the liquefied gas, thaw the iced pieces with warm water.
In case of contact with eyes: Rinse eyelids for at least 15 minutes with plenty of water and seek medical attention.

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 impairment.

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

Melaleuca Alternifolia Leaf Extract, Hypericum Perforatum Extract, Glycyrrhiza Glabra Root Extract, Aqua

Other Informations

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

LABEL

HAND AND SKIN SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79781-206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72.1 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79781-206-01	103 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/23/2020
2	NDC: 79781-206-02	257.5 g in 1 BOTTLE, SPRAY; 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(79781-206)

Revised: 9/2022

Document Id: e8ce18e1-3852-a3fe-e053-2995a90a0241

34390-5

Set id: a9d852de-ab99-81fa-e053-2995a90a4e70

Version: 3

Effective Time: 20220916

 

MOLECULE KORUYUCU SAGLIK U