SPL v1
SPL
SPL Set ID a56bb3a0-27c6-4279-8a24-d549153ed998
Route
TOPICAL
Published
Effective Date 2020-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Water Carbomer 934 Trolamine Aloe Vera Leaf .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-21
Description

Alcohol 75% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 75% v/v

Use

To Help reduce the on skin bacteria that could cause diseases

For use when soap and water are not available

Section 50565-1

Keep out of reach of children. If swallowed seek medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. This may be sign of serioous condition. Do not use on open skin wounds

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Avoid contact with broken skin

Do not inhale or ingest

Section 51945-4

Warnings

For external use only -hands

Flammable. Keep away from heat or flame

Do not use on chaildren less than two months of age

Directions
  • Place enough product on hands to cover entire surface. Rub hands together until dry. 
  • Supervise children under 6 years old when using this product to avoid swallowing
Other Information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat about 40C (104F)

Active Ingredient(s)

Alcohol 75% v/v

Inactive Ingredients

Water, glycerin, carbomer, triethanolamine, aloe barbadensis leaf extract, tocopheryl acetate

Structured Label Content

Use

To Help reduce the on skin bacteria that could cause diseases

For use when soap and water are not available

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed seek medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. This may be sign of serioous condition. Do not use on open skin wounds

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Avoid contact with broken skin

Do not inhale or ingest

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only -hands

Flammable. Keep away from heat or flame

Do not use on chaildren less than two months of age

Directions
  • Place enough product on hands to cover entire surface. Rub hands together until dry. 
  • Supervise children under 6 years old when using this product to avoid swallowing
Other Information (Other information)

Store between 15-30C (59-86F)

Avoid freezing and excessive heat about 40C (104F)

Active Ingredient(s)

Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water, glycerin, carbomer, triethanolamine, aloe barbadensis leaf extract, tocopheryl acetate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:39.192482 · Updated: 2026-03-14T22:56:53.457681