European Soaps - 100ml Number 63 Hand Purifying Gel

European Soaps - 100ml Number 63 Hand Purifying Gel
SPL v1
SPL
SPL Set ID e27e72f7-06e4-6e95-e053-2a95a90a3478
Route
TOPICAL
Published
Effective Date 2021-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.15 mL)
Inactive Ingredients
Trolamine Aloe Glycerin Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-02
Description

Ethyl Alcohol 70%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

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 Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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, flush thoroughly with water.

Warnings

For external use only. Flammable. Keep away from heat or flame. When using the product, keep out of eyes. Do not inhale or ingest.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Not recommended for infants
Do Not Use

on open skin wounds - around eyes - in ears and mouth

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor some fabrics
  • Harmful to wood finishes and plastics
Active Ingredient(s)

Ethyl Alcohol 70%

Inactive Ingredients



Aqua (Water), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Parfum (Fragrance), Triethanolamine, Aloe Barbadensis Leaf Juice Powder

Package Label Principal Display Panel

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 Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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, flush thoroughly with water.

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame. When using the product, keep out of eyes. Do not inhale or ingest.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Not recommended for infants
Do Not Use (Do not use)

on open skin wounds - around eyes - in ears and mouth

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor some fabrics
  • Harmful to wood finishes and plastics
Active Ingredient(s)

Ethyl Alcohol 70%

Inactive Ingredients (Inactive ingredients)



Aqua (Water), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Parfum (Fragrance), Triethanolamine, Aloe Barbadensis Leaf Juice Powder

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:15.778575 · Updated: 2026-03-14T23:00:37.728626