SPL v1
SPL
SPL Set ID 39f3126d-475c-41a3-84ae-110201249df5
Route
TOPICAL
Published
Effective Date 2020-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-13
Description

Alcohol 75% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 75% v/v.

Uses

Eliminate bacteria and viral matter on the skin.

Section 50565-1

Keep out of reach of children. In case of ingestion. seek medical help or contact a Poison Control Center immediately.

Warnings

Do not use

  • on children under 2 months of age
  • on open wounds

When using:

Avoid contact with face. eyes. and broken skin. In case of eye contact, flush with clean water and seek medical assistance.

Stop use and contact a doctor if:

Irritation or redness occurs.

Directions
  • Dispense a liberal amount of product on hands, enough to coat palms and fingers and then rub until dry.
  • Supervise small children to ensure proper usage and prevent ingestion.
Active Ingredient

Alcohol 75% v/v.

Other Information
  • Store below 110°F[43°C].
  • May discolor certain fabrics/surfaces.
Inactive Ingredients

Water, Aloe, Carbomer, Triethanolamine.

Package Label Principal Display Panel

Structured Label Content

Uses

Eliminate bacteria and viral matter on the skin.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of ingestion. seek medical help or contact a Poison Control Center immediately.

Purpose

Antiseptic

Warnings

Do not use

  • on children under 2 months of age
  • on open wounds

When using:

Avoid contact with face. eyes. and broken skin. In case of eye contact, flush with clean water and seek medical assistance.

Stop use and contact a doctor if:

Irritation or redness occurs.

Directions
  • Dispense a liberal amount of product on hands, enough to coat palms and fingers and then rub until dry.
  • Supervise small children to ensure proper usage and prevent ingestion.
Active Ingredient

Alcohol 75% v/v.

Other Information (Other information)
  • Store below 110°F[43°C].
  • May discolor certain fabrics/surfaces.
Inactive Ingredients (Inactive ingredients)

Water, Aloe, Carbomer, Triethanolamine.

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: 2026-02-15T11:57:54.886641 · Updated: 2026-03-14T22:57:13.712468