SPL v6
SPL
SPL Set ID a58a5e48-a093-3e5f-e053-2995a90ac8cb
Route
TOPICAL
Published
Effective Date 2020-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (1.45 mL)
Inactive Ingredients
Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-13
Description

Antiseptic, Alcohol Sanitizing Wipes

Purpose

Antiseptic, Alcohol Sanitizing Wipes

Medication Information

Purpose

Antiseptic, Alcohol Sanitizing Wipes

Description

Antiseptic, Alcohol Sanitizing Wipes

Use

Alcohol Sanitizing Wipes to help reduce bacteria on skin. For use when soap and water are not available.

Section 42229-5

This is a sanitizing wipe 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 sanitizing wipe 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:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.

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

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
  • Wipe hands thoroughly with product.
  • Supervise children under 6 years of age when using this product.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Tightly seal sticker and close lid between uses to prevent wipes from drying.
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • Dispose of wipes in trash after use. Do not flush.
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients

glycerin, hydrogen peroxide, RO pure water

Package Label Principal Display Panel

80 wipes b NDC: 77665-101-07

60 wipes b NDC: 77665-101-06

50 wipes b NDC: 77665-101-05

100 wipes NDC: 77665-101-04

1 wipe NDC: 77665-101-03

10 wipes NDC: 77665-101-02

50 wipes NDC: 77665-101-01

Structured Label Content

Use

Alcohol Sanitizing Wipes to help reduce bacteria on skin. For use when soap and water are not available.

Section 42229-5 (42229-5)

This is a sanitizing wipe 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 sanitizing wipe 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:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.

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

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, Alcohol Sanitizing Wipes

Warnings

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

Directions
  • Wipe hands thoroughly with product.
  • Supervise children under 6 years of age when using this product.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Tightly seal sticker and close lid between uses to prevent wipes from drying.
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • Dispose of wipes in trash after use. Do not flush.
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, RO pure water

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

80 wipes b NDC: 77665-101-07

60 wipes b NDC: 77665-101-06

50 wipes b NDC: 77665-101-05

100 wipes NDC: 77665-101-04

1 wipe NDC: 77665-101-03

10 wipes NDC: 77665-101-02

50 wipes NDC: 77665-101-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:52.858391 · Updated: 2026-03-14T23:00:02.948947