SPL v2
SPL
SPL Set ID 4f188d59-f854-3f99-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Aloe Vera Leaf Glycerin Propylene Glycol Carbomer Interpolymer Type A (55000 Cps) Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-05-09
Description

Active Ingredient Ethyl Alcohol 62%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not use in or near eyes. If eye contact occurs, flush thoroughly with water and seek medical care.

Avoid contact with broken skin.

Ingestion may cause alcohol poisoning. If ingested, contact a physician or local poison control center.

Indications and Usage

Uses

  • To decrease bacteria on the skin that could cause disease.
  • Recommended for repeated use.
Dosage and Administration

Directions

  • Pour product in hands.
  • Rub together
  • Let dry
  • For children under 6, use only under adult supervision.
Description

Active Ingredient Ethyl Alcohol 62%

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and seek medical attention if irritation or redness occurs.

Section 51727-6

Inactive Ingredients : Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance

Section 51945-4

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active Ingredient

Ethyl Alcohol 62%

Other Information

Store below 110 F/43 C

Structured Label Content

Indications and Usage (34067-9)

Uses

  • To decrease bacteria on the skin that could cause disease.
  • Recommended for repeated use.
Dosage and Administration (34068-7)

Directions

  • Pour product in hands.
  • Rub together
  • Let dry
  • For children under 6, use only under adult supervision.
Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not use in or near eyes. If eye contact occurs, flush thoroughly with water and seek medical care.

Avoid contact with broken skin.

Ingestion may cause alcohol poisoning. If ingested, contact a physician or local poison control center.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and seek medical attention if irritation or redness occurs.

Section 51727-6 (51727-6)

Inactive Ingredients : Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 62%

Other Information

Store below 110 F/43 C

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:21.746724 · Updated: 2026-03-14T22:54:46.340416