Unishield Hand Sanitizer Gel
FDA Label NDC 49314-0004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unishield for the product Unishield Hand Sanitizer (NDC 49314-0004). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient

Ethyl Alcohol, 75% v/v

Otc - Purpose

Purpose  Antiseptic

Indications & Usage

Uses

  • Hand sanitizer to help reduce bacteria that potentially can cause disease
  • For use when soap and water are not available

Warnings

Warnings

For external use only.

Flammable, keep away from heat or flame.

Do not use

  • In children less than two months of age
  • On open skin wounds

    • When using this product:

    • Keep out of eyes, ears, and mouth
    • In case of contact with eyes, rinse eyes throughly with water

      • Stop use and ask a doctor if irritation or rash occurs. They 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 or contact a Poison Control Center right away.

Dosage & Administration

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.

Storage And Handling

Other information

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

Inactive Ingredient

Inactive ingredients

acrylates/ C10-C30 alkyl acrylate crossploymer, aminomethyl propanol, aloe barbadensis leaf jiuce,denatonium benzoate,fragrance, glycerin,maltodextrin, propylene glycol, tocopheryl acetate, water

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