ONKO HEALTH ALCOHOL ANTISEPTIC WIPE- alcohol, isopropyl alcohol cloth

ONKO HEALTH ALCOHOL ANTISEPTIC WIPE by

Drug Labeling and Warnings

ONKO HEALTH ALCOHOL ANTISEPTIC WIPE by is a Otc medication manufactured, distributed, or labeled by ONKO PHARMACEUTICALS USA INC., SEKTOR KIMYA DETERJAN SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Alcohol 60% v/v.

Isopropyl alcohol 10 % v/v.

Purpose

Antiseptic

Use

• For sanitizing skin.
• Suitable for hygienic personal care and disinfectant cleansing within private spaces.
• For preparation of the skin prior to injection or venipuncture.

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

• with electrocautery procedures
• on open skin wounds

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For single pack;

Tear open pouch, remove towel.

Wipe injection site vigorously and discard. / Wet hands and wrists thoroughly for 15 seconds and discard.

Supervise children under 6 years of age.

For multi pack;

Open clip-lid.

Remove moist towels to clean skin as required.

Wipe injection site vigorously and discard. / Wet hands and wrists thoroughly for 15 seconds and discard.

Close lid when not in use to keep remaining towels moist.

Supervise children under 6 years of age.

Other information

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

Inactive ingredients

Glycerin, Fragrance, Water.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ONKO HEALTH ALCOHOL ANTISEPTIC WIPE 
alcohol, isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77283-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	10 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77283-002-01	1 in 1 POUCH	07/13/2020
1		5 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC: 77283-002-02	100 in 1 BOTTLE, PLASTIC	07/13/2020
2		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC: 77283-002-03	120 in 1 BOTTLE, PLASTIC	07/13/2020
3		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4	NDC: 77283-002-04	150 in 1 BOTTLE, PLASTIC	07/13/2020
4		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5	NDC: 77283-002-05	350 in 1 BOTTLE, PLASTIC	07/13/2020
5		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
6	NDC: 77283-002-06	400 in 1 BOTTLE, PLASTIC	07/13/2020
6		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7	NDC: 77283-002-07	450 in 1 BOTTLE, PLASTIC	07/13/2020
7		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
8	NDC: 77283-002-08	500 in 1 BOTTLE, PLASTIC	07/13/2020
8		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
9	NDC: 77283-002-09	550 in 1 BOTTLE, PLASTIC	07/13/2020
9		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
10	NDC: 77283-002-10	600 in 1 BOTTLE, PLASTIC	07/13/2020
10		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
11	NDC: 77283-002-11	700 in 1 BOTTLE, PLASTIC	07/13/2020
11		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
12	NDC: 77283-002-12	800 in 1 BOTTLE, PLASTIC	07/13/2020
12		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
13	NDC: 77283-002-13	900 in 1 BOTTLE, PLASTIC	07/13/2020
13		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
14	NDC: 77283-002-14	1000 in 1 BOTTLE, PLASTIC	07/13/2020
14		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
15	NDC: 77283-002-15	2000 in 1 BOTTLE, PLASTIC	07/13/2020
15		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
16	NDC: 77283-002-16	5000 in 1 BOTTLE, PLASTIC	07/13/2020
16		3.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/13/2020

Labeler - ONKO PHARMACEUTICALS USA INC. (114603246)

Establishment
Name	Address	ID/FEI	Business Operations
SEKTOR KIMYA DETERJAN SANAYI VE TICARET ANONIM SIRKETI		533132559	manufacture(77283-002)