52989-004

52989-004
SPL v2
SPL
SPL Set ID 055e4b27-1850-4178-9475-c6d85fdc50be
Route
TOPICAL
Published
Effective Date 2020-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Aminomethylpropanol Carbomer 940 Aloe Vera Leaf .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-06
Description

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v

Use

Hand sanitizer to help decrease bacteria that potentially can cause disease

For use when soap and water are not available

Section 50565-1

Keep out of reach of children. If swallowed, get immediate medical help or contact a Poison Control Center right away.

Section 51945-4

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, keep out of eyes, ears or mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

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
Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients

Water, Aminomethylpropanol, Carbomer 940, Aloe Vera Leaf, Alpha Tocopherol Acetate

Structured Label Content

Use

Hand sanitizer to help decrease bacteria that potentially can cause disease

For use when soap and water are not available

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get immediate medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Purpose

Antiseptic

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, keep out of eyes, ears or mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

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
Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water, Aminomethylpropanol, Carbomer 940, Aloe Vera Leaf, Alpha Tocopherol Acetate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:29.207682 · Updated: 2026-03-14T22:58:01.908948