2 In1 Hand Sanitizer/disinfectant

2 In1 Hand Sanitizer/disinfectant
SPL v2
SPL
SPL Set ID a58fe22b-45c8-3032-e053-2995a90a6f4a
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (1.5 mL)
Inactive Ingredients
Aloe Vera Leaf Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-25

Description

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients or higher in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations with slight concentration modifications: Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.5% v/v). Hydrogen peroxide (0.126% v/v). Distilled water. Aloe. Essential oil.

Purpose

Antiseptic, Hand Sanitizer & Surface Disinfectant


Medication Information

Purpose

Antiseptic, Hand Sanitizer & Surface Disinfectant

Description

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients or higher in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations with slight concentration modifications: Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.5% v/v). Hydrogen peroxide (0.126% v/v). Distilled water. Aloe. Essential oil.

Use

Hand Sanitize and surface disinfectantr to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients or higher in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations with slight concentration modifications:

  • Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.5% v/v).
  • Hydrogen peroxide (0.126% v/v).
  • Distilled water.
  • Aloe.
  • Essential oil.

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
  • Hands: Spray product in your palm. Rub hands together until dry.
  • Surface: Spray product 6-8 inches from surface until thoroughly wet. Wait about 10 seconds then wipe dry. Do not air dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May cause surface paint or fabric discoloration
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

glycerin, hydrogen peroxide, distilled water, aloe, essential oil

Package Label Principal Display Panel

473 ml NDC: 77509-070-01


Structured Label Content

Use

Hand Sanitize and surface disinfectantr to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5 (42229-5)

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients or higher in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations with slight concentration modifications:

  • Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.5% v/v).
  • Hydrogen peroxide (0.126% v/v).
  • Distilled water.
  • Aloe.
  • Essential oil.

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, Hand Sanitizer & Surface Disinfectant

Warnings

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

Directions
  • Hands: Spray product in your palm. Rub hands together until dry.
  • Surface: Spray product 6-8 inches from surface until thoroughly wet. Wait about 10 seconds then wipe dry. Do not air dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May cause surface paint or fabric discoloration
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, distilled water, aloe, essential oil

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

473 ml NDC: 77509-070-01


Advanced Ingredient Data


Raw Label Data

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