ONKO HEALTH ALCOHOL ANTISEPTIC WIPE

Manufacturer
ONKO PHARMACEUTICALS USA INC. | SEKTOR KIMYA DETERJAN SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:34:09

Label at a glance#

ProductONKO HEALTH ALCOHOL ANTISEPTIC WIPE
Active ingredientALCOHOL, ISOPROPYL ALCOHOL
Label structure9 sections

Dosage and administration

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 us...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 60% v/v.

Isopropyl alcohol 10 % v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Fragrance, Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FrontFront

BackBack

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77283-002-012022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-022022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-032022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-042022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-052022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-062022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-072022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-082022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-092022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-102022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-112022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-122022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-132022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-142022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-152022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6
77283-002-162022-01-28C16284748780-1d6a99b39-9952-a426-e053-dadaa90af4c2a7af4ea8-a84a-4431-92f7-181fabed98d6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77283-002-01ONKO HEALTH ALCOHOL ANTISEPTIC WIPE5 mL in 1 NOT APPLICABLECLOTH52
77283-002-01ONKO HEALTH ALCOHOL ANTISEPTIC WIPE1 in 1 POUCHCLOTH12
77283-002-02ONKO HEALTH ALCOHOL ANTISEPTIC WIPE100 in 1 BOTTLE, PLASTICCLOTH1002
77283-002-02ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-03ONKO HEALTH ALCOHOL ANTISEPTIC WIPE120 in 1 BOTTLE, PLASTICCLOTH1202
77283-002-03ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-04ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-04ONKO HEALTH ALCOHOL ANTISEPTIC WIPE150 in 1 BOTTLE, PLASTICCLOTH1502
77283-002-05ONKO HEALTH ALCOHOL ANTISEPTIC WIPE350 in 1 BOTTLE, PLASTICCLOTH3502
77283-002-05ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-06ONKO HEALTH ALCOHOL ANTISEPTIC WIPE400 in 1 BOTTLE, PLASTICCLOTH4002
77283-002-06ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-07ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-07ONKO HEALTH ALCOHOL ANTISEPTIC WIPE450 in 1 BOTTLE, PLASTICCLOTH4502
77283-002-08ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-08ONKO HEALTH ALCOHOL ANTISEPTIC WIPE500 in 1 BOTTLE, PLASTICCLOTH5002
77283-002-09ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-09ONKO HEALTH ALCOHOL ANTISEPTIC WIPE550 in 1 BOTTLE, PLASTICCLOTH5502
77283-002-10ONKO HEALTH ALCOHOL ANTISEPTIC WIPE600 in 1 BOTTLE, PLASTICCLOTH6002
77283-002-10ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-11ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-11ONKO HEALTH ALCOHOL ANTISEPTIC WIPE700 in 1 BOTTLE, PLASTICCLOTH7002
77283-002-12ONKO HEALTH ALCOHOL ANTISEPTIC WIPE800 in 1 BOTTLE, PLASTICCLOTH8002
77283-002-12ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-13ONKO HEALTH ALCOHOL ANTISEPTIC WIPE900 in 1 BOTTLE, PLASTICCLOTH9002
77283-002-13ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-14ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-14ONKO HEALTH ALCOHOL ANTISEPTIC WIPE1000 in 1 BOTTLE, PLASTICCLOTH10002
77283-002-15ONKO HEALTH ALCOHOL ANTISEPTIC WIPE2000 in 1 BOTTLE, PLASTICCLOTH20002
77283-002-15ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-16ONKO HEALTH ALCOHOL ANTISEPTIC WIPE3.12 mL in 1 NOT APPLICABLECLOTH3.122
77283-002-16ONKO HEALTH ALCOHOL ANTISEPTIC WIPE5000 in 1 BOTTLE, PLASTICCLOTH50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77283-002ONKO HEALTH ALCOHOL ANTISEPTIC WIPE (ALCOHOL, ISOPROPYL ALCOHOL) CLOTH [ONKO PHARMACEUTICALS USA INC.]2Legacy NDC, 32 package rows20201124_a7af4ea8-a84a-4431-92f7-181fabed98d6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9fd30434-f484-45db-adfd-1e974cbc6333a7af4ea8-a84a-4431-92f7-181fabed98d62020-11-20WarningsExact identifier
spl id: 9fd30434-f484-45db-adfd-1e974cbc6333
spl set id: a7af4ea8-a84a-4431-92f7-181fabed98d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.