b0653f73-0870-e62d-e053-2a95a90a3bcf

SPL v1
SPL
SPL Set ID b0653f73-0870-e62d-e053-2a95a90a3bcf
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (70 mL)
Inactive Ingredients
polyethylene glycol, unspecified glycerin water acrylates/vinyl isodecanoate crosspolymer (10000 mpa.s neutralized at 0.5%)

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-03-30
Purpose

Antiseptic, Hand Sanitizer

Description

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Isopropyl Alcohol (70%) (ACTIB) Water (IACT) Polyethylene Glycol, Unspecified (IACT) Aminomethylpropanol (IACT) Acrylates/Vinyl Isodecanoate Crosspolymer (10000 MPA.S Neeutranlized at 0.5% (IACT) Glycerin (IACT)

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

deionized water, polyethylene glycol, AMP-acrylates vinyl isodecanoate crosspolymer, glycerin

Description

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Isopropyl Alcohol (70%) (ACTIB) Water (IACT) Polyethylene Glycol, Unspecified (IACT) Aminomethylpropanol (IACT) Acrylates/Vinyl Isodecanoate Crosspolymer (10000 MPA.S Neeutranlized at 0.5% (IACT) Glycerin (IACT)

Use

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

Section 42229-5

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Isopropyl Alcohol (70%) (ACTIB)
  • Water (IACT)
  • Polyethylene Glycol, Unspecified (IACT)
  • Aminomethylpropanol (IACT)
  • Acrylates/Vinyl Isodecanoate Crosspolymer (10000 MPA.S Neeutranlized at 0.5% (IACT)
  • Glycerin (IACT)
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.

Section 50567-7

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

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

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

60 ml NDC: 79839-360-02

474 ml NDC: 79839-360-16

3780 ml NDC: 79839-360-01

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)

deionized water, polyethylene glycol, AMP-acrylates vinyl isodecanoate crosspolymer, glycerin

Use

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

Section 42229-5 (42229-5)

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Isopropyl Alcohol (70%) (ACTIB)
  • Water (IACT)
  • Polyethylene Glycol, Unspecified (IACT)
  • Aminomethylpropanol (IACT)
  • Acrylates/Vinyl Isodecanoate Crosspolymer (10000 MPA.S Neeutranlized at 0.5% (IACT)
  • Glycerin (IACT)
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.

Section 50567-7 (50567-7)

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

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

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

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

60 ml NDC: 79839-360-02

474 ml NDC: 79839-360-16

3780 ml NDC: 79839-360-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:48.894132 · Updated: 2026-03-14T22:58:34.944897