Hand Sanitizer
FDA Label NDC 69394-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aakron Rule Corporation for the product Hand Sanitizer (NDC 69394-001). 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, purpose, use(s), 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 Ingredient

Alcohol 80% v/v.

Purpose

Antiseptic

Use(S)

helps reduce bacteria that can cause disease when soap and water are not available.

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 avoid mouth, eyes, and ears. In case of contact with eyes, flush with water .

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help and call Poison Control.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age.

Other Information

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

Inactive Ingredients

Glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

Label (Label)

Label (Label)

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