SPL v1
SPL
SPL Set ID a2b53443-ef8c-cd4a-e053-2995a90a0fb2
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Trolamine Carbomer Homopolymer, Unspecified Type Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30
Description

Alcohol 75% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 75% v/v

Use

Hand sanitizing for intact skin

Section 50565-1

Keep out of reach of children.

Section 50566-9

Pruritus, redness, and swelling of hands, allergy, etc.

Warnings
  • External use, keep out of reach of children, avoid eyes and ear.
  • Use with caution for who allergic to ethanol.
  • Keep away from light, sealed, moisture-prood, store in a cool, dry place.
  • Flammable. Keep away from fire or flame
Directions
  • Wet hand with proper amount of the product, and keep the liquid for 1 minute until the liquid covers the whole hand and dry.
  • Children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Do not store above 40C. May discolor some fabrics and surfaces.
  • Store between 15-30C
Active Ingredient(s)

Alcohol 75% v/v

Inactive Ingredients

Water, Triethanolamine, Carbomer

Package Label Principal Display Panel

Structured Label Content

Use

Hand sanitizing for intact skin

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Pruritus, redness, and swelling of hands, allergy, etc.

Purpose

Antiseptic

Warnings
  • External use, keep out of reach of children, avoid eyes and ear.
  • Use with caution for who allergic to ethanol.
  • Keep away from light, sealed, moisture-prood, store in a cool, dry place.
  • Flammable. Keep away from fire or flame
Directions
  • Wet hand with proper amount of the product, and keep the liquid for 1 minute until the liquid covers the whole hand and dry.
  • Children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Do not store above 40C. May discolor some fabrics and surfaces.
  • Store between 15-30C
Active Ingredient(s)

Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water, Triethanolamine, Carbomer

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: 2026-02-15T11:57:10.184503 · Updated: 2026-03-14T22:56:07.308923