SPL v1
SPL
SPL Set ID b021df64-b9ff-13a2-e053-2a95a90af28e
Route
TOPICAL
Published
Effective Date 2020-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (0.15 mL)
Inactive Ingredients
Water Edetate Sodium Glycerin Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-21
Description

This is a hand sanitizing & moisturizing wipes manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry. The hand sanitizing & moisturizing wipes are 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: Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (67%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerin Sodium EDTA PEG 40 Hydrogenated Castor Oil Fragrance Aqua. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product

Purpose

Antimicrobial, Antibacterial Hand sanitizing and moisturizing wipes

Medication Information

Purpose

Antimicrobial, Antibacterial Hand sanitizing and moisturizing wipes

Description

This is a hand sanitizing & moisturizing wipes manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry. The hand sanitizing & moisturizing wipes are 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: Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (67%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerin Sodium EDTA PEG 40 Hydrogenated Castor Oil Fragrance Aqua. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product

Use

Hand Sanitizing wipes 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 sanitizing & moisturizing wipes manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizing & moisturizing wipes are 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:

Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (67%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Glycerin

Sodium EDTA

PEG 40 Hydrogenated Castor Oil

Fragrance

Aqua.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product

Section 43683-2

Hand sanitizing wipes to help reduce bacteria that potentially can cause disease. for use when soap and water are not available.

Wipe hands thoroughly with a towelette. Allow to dry. Discard after a single-use. For External use only.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

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 at 1-800-222-1222

Section 51945-4

Warnings

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

Directions
  • Wipe hands thoroughly with a towelette. Allow to dry. Discard after a single-use. For External use only.

Do Not Use
  • in children less than 2 months of age
  • on injured or irritated skin
  • If you are sensitive to any of its ingredients
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Isopropyl Alcohol 67% v/v. Purpose: Antimicrobial, Antibacterial

Inactive Ingredients

Aqua, Glycerin, Sodium EDTA, PEG 40 Hydrogenated Castor Oil, Fragrance

Structured Label Content

Use

Hand Sanitizing wipes 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 sanitizing & moisturizing wipes manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizing & moisturizing wipes are 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:

Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (67%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Glycerin

Sodium EDTA

PEG 40 Hydrogenated Castor Oil

Fragrance

Aqua.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product

Section 43683-2 (43683-2)

Hand sanitizing wipes to help reduce bacteria that potentially can cause disease. for use when soap and water are not available.

Wipe hands thoroughly with a towelette. Allow to dry. Discard after a single-use. For External use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

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 at 1-800-222-1222

Section 51945-4 (51945-4)

Purpose

Antimicrobial, Antibacterial Hand sanitizing and moisturizing wipes

Warnings

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

Directions
  • Wipe hands thoroughly with a towelette. Allow to dry. Discard after a single-use. For External use only.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on injured or irritated skin
  • If you are sensitive to any of its ingredients
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Isopropyl Alcohol 67% v/v. Purpose: Antimicrobial, Antibacterial

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Sodium EDTA, PEG 40 Hydrogenated Castor Oil, Fragrance

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:50.643802 · Updated: 2026-03-14T22:58:36.589882