SPL v1
SPL
SPL Set ID a8fd312b-e801-1ec3-e053-2995a90a6670
Route
TOPICAL
Published
Effective Date 2020-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 mL)
Inactive Ingredients
Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-29

Description

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.

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

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.

Use

Sanitizer to help reduce bacteria on the skin that could cause disease. Recommeded for repeated use

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 43683-2

Warnings:

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Uses:

  • Sanitizer to help reduce bacteria on the skin that could cause diease
  • Recommended for repeated use

Directions:

  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly unitl dry
  • Children under 6 years of age should be supervised when using this 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 appears and lasts

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.



Stop use and ask a doctor if irritation or rash appears and lasts.



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

Warnings

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

Directions
  • Place enough product in your palm to thoroughly cover your hands.
  • Rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product
Do Not Use
  • for children less than 2 months of age
  • on open skin wounds.
Other Information
  • Store below 110 oF (43 oC)
  • May discolor certain fabrics or surfaces
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

Glycerin, hydrogen peroxide, purified water USP

Package Label Principal Display Panel

18900 mL NDC: 77183-5195-0

18900mL in ONE PAIL


Structured Label Content

Use

Sanitizer to help reduce bacteria on the skin that could cause disease. Recommeded for repeated use

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 43683-2 (43683-2)

Warnings:

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Uses:

  • Sanitizer to help reduce bacteria on the skin that could cause diease
  • Recommended for repeated use

Directions:

  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly unitl dry
  • Children under 6 years of age should be supervised when using this 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 appears and lasts

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.



Stop use and ask a doctor if irritation or rash appears and lasts.



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

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

Directions
  • Place enough product in your palm to thoroughly cover your hands.
  • Rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product
Do Not Use (Do not use)
  • for children less than 2 months of age
  • on open skin wounds.
Other Information (Other information)
  • Store below 110 oF (43 oC)
  • May discolor certain fabrics or surfaces
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Glycerin, hydrogen peroxide, purified water USP

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

18900 mL NDC: 77183-5195-0

18900mL in ONE PAIL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)