ac4f56ff-b2dd-6f2a-e053-2a95a90ac7fe

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
Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 80% v/v. Purpose: Antiseptic

Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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.
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

water, glycerin,hydroxypropyl cellulose

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.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

3785 ml NDC 75083-007-28

Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

water, glycerin,hydroxypropyl cellulose

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.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

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