SPL v2
SPL
SPL Set ID a611c0d7-ad08-6c2d-e053-2a95a90a6ee6
Route
TOPICAL
Published
Effective Date 2020-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Trolamine Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Water Glycerin Butylene Glycol Hyaluronate Sodium 1,2-hexanediol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-19
Description

Alcohol 75% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 75% v/v

Use
  • Hand sanitizer to help reduce bacteria that potentially can 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 or rash occurs. These may be signs of serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Directions
  • Place enough product on your palm to thoroughly cover your hands.
  • Rub hands together briskly until dry.
  • Supervise children when using this product to avoid swallowing.
Active Ingredient

Alcohol 75% v/v

Other Information
  • Store between 15-30 °C (59-86°F).
  • Avoid freezing and excessive heat above 104°F(40°C).
  • May discolor certain fabrics or surface.
Inactive Ingredients

Water, Butylene Glycol, Glycerin, Aloe Vera Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Package Label Principal Display Panel

Structured Label Content

Use
  • Hand sanitizer to help reduce bacteria that potentially can 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 or rash occurs. These may be signs of serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame.

Directions
  • Place enough product on your palm to thoroughly cover your hands.
  • Rub hands together briskly until dry.
  • Supervise children when using this product to avoid swallowing.
Active Ingredient

Alcohol 75% v/v

Other Information
  • Store between 15-30 °C (59-86°F).
  • Avoid freezing and excessive heat above 104°F(40°C).
  • May discolor certain fabrics or surface.
Inactive Ingredients

Water, Butylene Glycol, Glycerin, Aloe Vera Leaf, Sodium Hyaluronate, 1,2-Hexanediol

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: 2026-02-15T11:57:49.849627 · Updated: 2026-03-14T22:57:06.397974