ONKOHEALTH HAND AND SURFACE SANITIZER- alcohol liquid
ONKO PHARMACEUTICALS USA INC.

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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Active Ingredient

Alcohol 80% v/v.

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Product Labels

image description

ONKOHEALTH HAND AND SURFACE SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77283-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77283-001-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020
2	NDC:77283-001-02	150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020
3	NDC:77283-001-03	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020
4	NDC:77283-001-04	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020
5	NDC:77283-001-05	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020
6	NDC:77283-001-06	3790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020
7	NDC:77283-001-07	10000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020
8	NDC:77283-001-08	20000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020
9	NDC:77283-001-09	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/11/2020

Labeler - ONKO PHARMACEUTICALS USA INC. (114603246)

Name	Address	ID/FEI	Business Operations
Establishment
CALDINI KIMYA SANAYI VE TICARET LIMITED SIRKETI		504596538	manufacture(77283-001)

Name	Address	ID/FEI	Business Operations
Establishment
SEKTOR KIMYA DETERJAN SANAYI VE TICARET ANONIM SIRKETI		533132559	manufacture(77283-001)