SPL v1
SPL
SPL Set ID fbd20d4a-ad8c-4905-a9e7-b0eb146547e9
Route
TOPICAL
Published
Effective Date 2020-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Glycerin Propylene Glycol Trolamine .alpha.-tocopherol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-07
Description

Ethyl Alcohol 75% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v.

Uses

Hand Sanitizer to help decrease bacteria on the skin.

When water, soap and towel are not available.

Recommended for repeated use.

Section 50565-1

Keep out of reach of children. Children must be superwised in use of of this product.

Warnings

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

Do not use

in children less than 2 months of age

on open skin wounds.

When using this product avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

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.
Product Label

Active Ingredient

Ethyl Alcohol 75% v/v.

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

aloe vera gel, carbomer, glycerin, propylene glycol, triethanolamine, Vitamin E, water

Structured Label Content

Uses

Hand Sanitizer to help decrease bacteria on the skin.

When water, soap and towel are not available.

Recommended for repeated use.

Section 50565-1 (50565-1)

Keep out of reach of children. Children must be superwised in use of of this product.

Purpose

Antiseptic

Warnings

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

Do not use

in children less than 2 months of age

on open skin wounds.

When using this product avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

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.
Product Label

Active Ingredient

Ethyl Alcohol 75% v/v.

Other Information (Other information)
  • Store between 15°-30°C (59°-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)

aloe vera gel, carbomer, glycerin, propylene glycol, triethanolamine, Vitamin E, water

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:29.663296 · Updated: 2026-03-14T22:56:40.798179