Loro

Loro
SPL v7
SPL
SPL Set ID a856e799-0b8d-d9b4-e053-2995a90a5eb7
Route
TOPICAL
Published
Effective Date 2020-03-28
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 2020-03-30

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

Hand Sanitizer to help reduce bacteria on the skin.

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.

Warnings

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

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • Children under 6 years of age should be supervised when using LORO
Other Information
  • Store below 110 Degree F (43 Degree C)
  • May discolor certain fabrics or surfaces

Manufacture By:

Hanoi Biology Chemistry Group Corporation

252/57 Tay Son, Trung Liet Ward, Dong Da District

Hanoi, Vietnam

Active Ingredient(s)

Ethyl Alcohol 70%, Isopropyl Alcohol 0.5%. Purpose: Antiseptic

Inactive Ingredients

Water (Aqua), Glycerin, Ginger Oil.

When Using This Product

do not use in or near eyes. In case of contact with eyes, 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.

Stop Use and Ask A Doctor If:

irritation or rash appears and lasts.

Package Label Principal Display Panel

474 mL NDC: 78185-005-01


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the skin.

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.

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • Children under 6 years of age should be supervised when using LORO
Other Information (Other information)
  • Store below 110 Degree F (43 Degree C)
  • May discolor certain fabrics or surfaces

Manufacture By:

Hanoi Biology Chemistry Group Corporation

252/57 Tay Son, Trung Liet Ward, Dong Da District

Hanoi, Vietnam

Active Ingredient(s)

Ethyl Alcohol 70%, Isopropyl Alcohol 0.5%. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Ginger Oil.

When Using This Product (When using this product)

do not use in or near eyes. In case of contact with eyes, 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.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

irritation or rash appears and lasts.

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

474 mL NDC: 78185-005-01


Advanced Ingredient Data


Raw Label Data

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