SPL v2
SPL
SPL Set ID f2f03954-f47c-43f7-be63-376959b2059e
Route
TOPICAL
Published
Effective Date 2020-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-26
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 & towel are not available.
  • Recommended for repealed use.
Section 50565-1

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

Warnings
  • For external use only
  • Flammable. Keep away from fire or flame.
  • Do not apply around eyes. Do not use in ears & mouth.
  • 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
  • Pump as needed into your palms and thoroughly spread on both hand.
  • Rub into skin until dry.
Active Ingredient

Ethyl Alcohol 75% v/v.

Other Information
  • Store at 20oC (88-77oF).
  • May discolor fabrics.
Inactive Ingredients

Water, Glycerin, Aloe barbadensis leaf extract, Carbomer, Tocopheryl Acetate, Triethanolamine.

Package Label Principal Display Panel

60 mL

100 mL

237 mL

500 mL

Structured Label Content

Uses
  • Hand sanitizer to help decrease bacteria on the skin.
  • When water, soap & towel are not available.
  • Recommended for repealed use.
Section 50565-1 (50565-1)

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

Purpose

Antiseptic

Warnings
  • For external use only
  • Flammable. Keep away from fire or flame.
  • Do not apply around eyes. Do not use in ears & mouth.
  • 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
  • Pump as needed into your palms and thoroughly spread on both hand.
  • Rub into skin until dry.
Active Ingredient

Ethyl Alcohol 75% v/v.

Other Information (Other information)
  • Store at 20oC (88-77oF).
  • May discolor fabrics.
Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Aloe barbadensis leaf extract, Carbomer, Tocopheryl Acetate, Triethanolamine.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

60 mL

100 mL

237 mL

500 mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:25.966413 · Updated: 2026-03-14T22:57:57.287270