SPL v1
SPL
SPL Set ID a6c6afb0-20b7-236f-e053-2a95a90a522a
Route
TOPICAL
Published
Effective Date 2020-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Hyaluronate Sodium Alpha-tocopherol Acetate Aloe Vera Leaf Tromethamine Propylene Glycol Glycerin Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Water Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-29
Description

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62% v/v

Use
  • to decrease bacteria on the skin that could cause disease
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • irritation and rash occurs. These may be signs of serious condition
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
Warnings

For external use only : hands

Flammable. Keep away from heat or flame.

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry
  • Children under 6 years should be supervised when using this product
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • Do not use on children under two months of age.
Active Ingredient(s)

Ethyl Alcohol 62% v/v

Inactive Ingredients

Water, Carbomer, Tromethamin, Glycerin, Propylene Glycol, Panthenol, Aloe Barbadensis Leaf, Sodium Hyalunate, Tocopheryl Acetate

Package Label Principal Display Panel

Structured Label Content

Use
  • to decrease bacteria on the skin that could cause disease
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • irritation and rash occurs. These may be signs of serious condition
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
Purpose

Antiseptic

Warnings

For external use only : hands

Flammable. Keep away from heat or flame.

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry
  • Children under 6 years should be supervised when using this product
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • Do not use on children under two months of age.
Active Ingredient(s)

Ethyl Alcohol 62% v/v

Inactive Ingredients (Inactive ingredients)

Water, Carbomer, Tromethamin, Glycerin, Propylene Glycol, Panthenol, Aloe Barbadensis Leaf, Sodium Hyalunate, Tocopheryl Acetate

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:45.231715 · Updated: 2026-03-14T22:57:00.206654