SPL v1
SPL
SPL Set ID 20784157-bdb1-4472-b267-4b94fcb8409d
Route
TOPICAL
Published
Effective Date 2020-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-20
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 repeated 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 heat 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
  • place enough product into your palms and thoroughly spread on both hands.
  • rub into skin until dry.

Other information

store below 110 ℉ (43 ℃ ).

may discolor certain fabrics or surfaces.

Active Ingredient

Ethyl Alcohol 75% v/v.

Inactive Ingredients

carbomer, water.

Package Label Principal Display Panel

Label 500 mL

Label 1000 mL

Structured Label Content

Uses
  • hand sanitizer to help decrease bacteria on the skin, when water, soap & towel are not available.
  • recommended for repeated 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 heat 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
  • place enough product into your palms and thoroughly spread on both hands.
  • rub into skin until dry.

Other information

store below 110 ℉ (43 ℃ ).

may discolor certain fabrics or surfaces.

Active Ingredient

Ethyl Alcohol 75% v/v.

Inactive Ingredients (Inactive ingredients)

carbomer, water.

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

Label 500 mL

Label 1000 mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:39.139266 · Updated: 2026-03-14T22:56:53.457681