Onko Health Alcohol Antiseptic Wipe
FDA Label NDC 77283-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Onko Pharmaceuticals Usa Inc. for the product Onko Health Alcohol Antiseptic Wipe (NDC 77283-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - 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

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