SPL v1
SPL
SPL Set ID 70522323-7a04-34e6-e053-2991aa0a8282
Route
TOPICAL
Published
Effective Date 2018-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Maltodextrin Aloe Vera Leaf Water Glycerin Propylene Glycol Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-07-06
Description

Active ingredient: Ethyl alcohol 62%

Medication Information

Warnings and Precautions

Warnings

For external use only: hands

Flammable. Keep away from heat and flame.

Indications and Usage

Uses to decrease bacteria on the skin that could cause disease. recommended for repeated use

Dosage and Administration

Directions

  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, ues only under adult supervision
  • not recommended for infants

Description

Active ingredient: Ethyl alcohol 62%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • irritation or redness develops
  • condition persists for more that 72 hours
Section 50567-7

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin
  • do not inhale or ingest
Section 51727-6

Inactive ingredients

water, glycerin, propylene glycol, acrylates/C10-C30 alkyl acrylate crosspolymer, triethanolamine, aloe barbadensis leaf juice, maltodextrin

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredient:

Ethyl alcohol 62%

Section 60561-8

Other Information

  • do not store above 105F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

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

  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, ues only under adult supervision
  • not recommended for infants

Warnings and Precautions (34071-1)

Warnings

For external use only: hands

Flammable. Keep away from heat and flame.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • irritation or redness develops
  • condition persists for more that 72 hours
Section 50567-7 (50567-7)

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin
  • do not inhale or ingest
Section 51727-6 (51727-6)

Inactive ingredients

water, glycerin, propylene glycol, acrylates/C10-C30 alkyl acrylate crosspolymer, triethanolamine, aloe barbadensis leaf juice, maltodextrin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredient:

Ethyl alcohol 62%

Section 60561-8 (60561-8)

Other Information

  • do not store above 105F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:36.153952 · Updated: 2026-03-14T22:55:11.113899