Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel

Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel
SPL v1
SPL
SPL Set ID ae42a017-83e8-56f2-e053-2995a90aa844
Route
TOPICAL
Published
Effective Date 2020-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (70 mL)
Inactive Ingredients
Hydroxymethyl Cellulose Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-31
Description

This is a hand sanitizer manufactured according to the part333A of the OTC monograph. The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentag formulation) a. Isopropyl Alcohol (70%, v/v) in an aqueos solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. b. Glycerol (1.5% v/v). c. Hydroxymethyl Cellulose (1.3% v/v) . d. Sterile distilled water or boiled cold water.

Purpose

Antiseptic, Hand Sanitizer

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

This is a hand sanitizer manufactured according to the part333A of the OTC monograph. The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentag formulation) a. Isopropyl Alcohol (70%, v/v) in an aqueos solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. b. Glycerol (1.5% v/v). c. Hydroxymethyl Cellulose (1.3% v/v) . d. Sterile distilled water or boiled cold water.

Use

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

Section 42229-5

This is a hand sanitizer manufactured according to the part333A of the OTC monograph.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentag

formulation)

a. Isopropyl Alcohol (70%, v/v) in an aqueos solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

b. Glycerol (1.5% v/v).

c. Hydroxymethyl Cellulose (1.3% v/v) .

d. Sterile distilled water or boiled cold water.

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.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

glycerin, methylcellulose, purified water USP

Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel

18927000 ml NDC: 71158-004-01

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 42229-5 (42229-5)

This is a hand sanitizer manufactured according to the part333A of the OTC monograph.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentag

formulation)

a. Isopropyl Alcohol (70%, v/v) in an aqueos solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

b. Glycerol (1.5% v/v).

c. Hydroxymethyl Cellulose (1.3% v/v) .

d. Sterile distilled water or boiled cold water.

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.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

glycerin, methylcellulose, purified water USP

Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel

18927000 ml NDC: 71158-004-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:37.157650 · Updated: 2026-03-14T22:58:16.152732