Gel Hand and Skin Disinfectant

Gel Hand and Skin Disinfectant by

Drug Labeling and Warnings

Gel 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]

GEL HAND AND SKIN DISINFECTANT- alcohol gel 
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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Gel Hand and Skin Disinfectant

%73 ALCOHOL (w/w)

Antiseptic

Ready-to-use gel for hands and skin. It helps reduce bacteria that potentially can cause disease. For use when soap and water are not available

Apply 3-5 ml to the palm of your hand, spread over your entire hand and rub it in until dry. Repeat the process according to the hygiene situation. It is recommended to be used in its original packaging.

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

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

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water. If symptoms persist, seek medical attention. After skin contact: If symptoms develop, seek medical attention. After swallowing: DO NOT vomit if swallowed. Let the victim drink plenty of water. Get medical attention immediately. After inhalation: No expected symptoms. Seek medical attention if symptoms
develop.

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.

Glycerin, Carbomer, Melaleuca Alternıfolia Leaf Oil, Hypericum Perforatum Oil, T riethanolamine ,Aqua (Deiyonize su)

Other information

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

GEL HAND AND SKIN DISINFECTANT 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79781-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
GLYCERIN (UNII: PDC6A3C0OX)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
CARBOMER 1342 (UNII: 809Y72KV36)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79781-214-04	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2020
2	NDC: 79781-214-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2020
3	NDC: 79781-214-03	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2020
4	NDC: 79781-214-02	150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/24/2020	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(79781-214)

Revised: 9/2022

Document Id: e8ce383b-a2ad-0f5c-e053-2995a90a553d

34390-5

Set id: af4317d0-0fde-f3b3-e053-2a95a90ab720

Version: 4

Effective Time: 20220916

 

MOLECULE KORUYUCU SAGLIK U