OUSTANE HAND SANITIZER- alcohol gel

Oustane Hand Sanitizer by

Drug Labeling and Warnings

Oustane Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cadence Keen Innovations, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

Hand washing to reduce bacteria on skin, suitable when water is unavailable

Warnings

External Use only
Flammable, keep away from fire or flame

When using this product

Avoid contact with eyes, rinse thoroughly with water if contact occurs

Stop using and ask a doctor if

Skin irritation or redness develop or increase

Keep out of reach of children

If swallowed, get medical attention or contact a Poison Control Center right away.

Directions

• Pour suitable enough product in your palm and rub together until dry.
• Children under 8 years of age should be used under supervision.

Inactive Ingredients

Water, Parfum(fragance), Propanediol, Polysorbate 20, Glycerin

Other Information

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

Package Labeling: 50ml

Package Labeling: 500ml

Package Labeling:3.785L

INGREDIENTS AND APPEARANCE

OUSTANE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79128-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79128-000-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/22/2020
2	NDC: 79128-000-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/22/2020
3	NDC: 79128-000-37	3785 mL in 1 DRUM; Type 0: Not a Combination Product	06/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/22/2020

Labeler - Cadence Keen Innovations, Inc. (020785510)