SPL v2
SPL
SPL Set ID ac4f56ff-b2dd-6f2a-e053-2a95a90ac7fe
Route
TOPICAL
Published
Effective Date 2020-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 mL)
Inactive Ingredients
Glycerin Hydroxypropyl Cellulose, Unspecified Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-01
Description

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 80% v/v. Purpose: Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 a serious condition.

Warnings

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

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise 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
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

water, glycerin,hydroxypropyl cellulose

Package Label Principal Display Panel

3785 ml NDC 75083-007-28

Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 a serious condition.

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise 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)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

water, glycerin,hydroxypropyl cellulose

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

3785 ml NDC 75083-007-28

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:21.473971 · Updated: 2026-03-14T22:59:16.552832