OSSION HAND SANITIZER- ethanol aerosol 
SORA KOZMETIK SANAYI 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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Ossion

Active Ingredient

Ethanol 90.24%

Purpose

Antiseptic

Use

It is used for local disinfection of hands and skin. It is effective against microbes and bacteria. It provides easiness and hygiene in at home, at work, in crowded environments.

Warnings

For external use only.

DANGER: Flammable. Contents Under Pressure.

Do not use near heat, sparks, or flames. Vapors may ignite explosively & cause flash fire. Prevent build-up of vapors. Do not smoke. Turn off pilot light, stoves, heaters, and other sources of ignition during use and until all vapors are gone. Do not puncture or incinerate container. Do not expose to heat or store at temperatures about 120F. Use with adequate ventilation.

Stop use and ask a doctor if irritation and redness develops.

Avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical attention.

Keep out of reach of children.

Keep out of reach of children and pets: Children under 6 years age should be supervised by an adult when using. If swallowed, get medical help or contact your Poison Control Center right away.

Directions

Take a suffiicent amount in your palm and spread over the entirety of your hand and fingers. Wait for about 30 seconds for your hands to dry.

Other information

Store at room temperature or in a cool place.

Inactive ingredients

Water, Panthenol (Vitamin B5), Glycerol, Tocopheryl Acetate (Vitamin E), Aloe Barbadensis (Aloe Vera) Leaf Juice.

Package Label - Principal Display Panel

Ossion

OSSION HAND SANITIZER 
ethanol aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77462-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL90.24 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PANTHENOL (UNII: WV9CM0O67Z)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77462-002-05150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/18/2020
Labeler - SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI (366418499)
Establishment
NameAddressID/FEIBusiness Operations
SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI366418499manufacture(77462-002)

Revised: 6/2020
Document Id: a8602ef3-bf31-6bec-e053-2995a90ad0a8
Set id: a85ff850-d2a8-06c3-e053-2a95a90a59fb
Version: 1
Effective Time: 20200618
 
SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI