Alcohol Antiseptic 80%
FDA Label NDC 58602-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Alcohol Antiseptic 80% (NDC 58602-004). 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 ingredient(s), purpose, use(s), warnings, do not use, when using this product, stop use and ask doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Alcohol 80% v/v

Purpose

Antiseptic

Use(S)

Health care personnel hand rub to help reduce bacteria that potentially causes disease.

Warnings

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

Do Not Use

  • in children less than 2 months of age
  • on open skin wounds

When Using This Product

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

Stop Use And Ask Doctor If

Stop using and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

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

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

Inactive Ingredient Section

glycerin, hydrogen peroxide, purified water USP

Questions Or Comments

Call 1-855-274-4122

Principal Display Panel

AUROHEALTH
NDC 58602-004-38
Alcohol Aniseptic 80%
Topical Solution
Antiseptic Hand Rub
Non-sterile Solution
128 OZ (3785 mL)


Alcohol (Alcohol)

Alcohol (Alcohol)

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