OSSION HAND SANITIZER- ethanol aerosol

Ossion Hand Sanitizer by

Drug Labeling and Warnings

Ossion Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

WHEN USING

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.

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

INGREDIENTS AND APPEARANCE

OSSION HAND SANITIZER 
ethanol aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77462-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	90.24 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77462-002-05	150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/18/2020

Labeler - SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI (366418499)

Establishment
Name	Address	ID/FEI	Business Operations
SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI		366418499	manufacture(77462-002)