SPL v1
SPL
SPL Set ID cdc26d4d-7d26-4af7-a004-2488c6582781
Route
TOPICAL
Published
Effective Date 2020-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Polysorbate 20 Water Aloe Orange Peel Maltodextrin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-09

Description

This is a hand rub manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Rub Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand rub 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) Glycerol. Hydrogen peroxide. Sterile distilled water.

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

This is a hand rub manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Rub Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand rub 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) Glycerol. Hydrogen peroxide. Sterile distilled water.

Use

Hand Sanitizer to help reduce bacteria on the skin

Section 42229-5

This is a hand rub manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Rub Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand rub 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)
  • Glycerol.
  • Hydrogen peroxide.
  • Sterile distilled water.
Section 50565-1

Keep this and all drugs 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 eyes. If contact occurs, rinse eyes thoroughly with water.

Warnings

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

Directions
  • Put enough product in your palm to cover hands and rub together briskly until dry. 
  • Children under 6 years of age should be supervised when using this product.
Do Not Use
  • in or around eyes
Other Information
  • Store below 110F (43C)
  • May discolor certain fabrics or surfaces
Active Ingredient(s)

Ethyl Alcohol 70%. Purpose: Antiseptic

Inactive Ingredients

deionized water, glycerin, polysorbate 20, aloe barbadensis leaf juice, orange peel oil, tocopheryl acetate, maltodextrin, parfum

Package Label Principal Display Panel


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the skin

Section 42229-5 (42229-5)

This is a hand rub manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Rub Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand rub 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)
  • Glycerol.
  • Hydrogen peroxide.
  • Sterile distilled water.
Section 50565-1 (50565-1)

Keep this and all drugs 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 eyes. If contact occurs, rinse eyes thoroughly with water.

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

Directions
  • Put enough product in your palm to cover hands and rub together briskly until dry. 
  • Children under 6 years of age should be supervised when using this product.
Do Not Use (Do not use)
  • in or around eyes
Other Information (Other information)
  • Store below 110F (43C)
  • May discolor certain fabrics or surfaces
Active Ingredient(s)

Ethyl Alcohol 70%. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

deionized water, glycerin, polysorbate 20, aloe barbadensis leaf juice, orange peel oil, tocopheryl acetate, maltodextrin, parfum

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


Advanced Ingredient Data


Raw Label Data

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