loro

loro
SPL v12
SPL
SPL Set ID ae2420f1-f91e-0b39-e053-2a95a90a2089
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL) isopropyl alcohol (0.05 mL)
Inactive Ingredients
ginger oil glycerin water carbomer interpolymer type a (55000 cps)

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-03-30

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) (70%, 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 (0.25% v/v). Isopropyl Alcohol (0.2% v/v). Sterile distilled water or boiled cold water (29% v/v). Acrylite Crosspolymer (0.5% v/v). Ginger Oil (0.05% v/v) The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.


Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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.
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

Inactive Ingredients

Water (Aqua), Acrylite Crosspolymer, Glycerine, Ginger Oil.

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) (70%, 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 (0.25% v/v). Isopropyl Alcohol (0.2% v/v). Sterile distilled water or boiled cold water (29% v/v). Acrylite Crosspolymer (0.5% v/v). Ginger Oil (0.05% v/v) 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) (70%, 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 (0.25% v/v).
  • Isopropyl Alcohol (0.2% v/v).
  • Sterile distilled water or boiled cold water (29% v/v).
  • Acrylite Crosspolymer (0.5% v/v).
  • Ginger Oil (0.05% v/v)

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 appears and lasts.

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.

Do Not Use
  • Children under 6 years of age should be supervised when using LORO
Active Ingredient(s)

Tehyl Alcohol 70% v/v, Isopropyl Alcohol 0.5%. Purpose: Antiseptic

Package Label Principal Display Panel

237 mL NDC: 78185-010-01


Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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.
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

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Acrylite Crosspolymer, Glycerine, Ginger Oil.

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) (70%, 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 (0.25% v/v).
  • Isopropyl Alcohol (0.2% v/v).
  • Sterile distilled water or boiled cold water (29% v/v).
  • Acrylite Crosspolymer (0.5% v/v).
  • Ginger Oil (0.05% v/v)

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 appears and lasts.

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.

Do Not Use (Do not use)
  • Children under 6 years of age should be supervised when using LORO
Active Ingredient(s)

Tehyl Alcohol 70% v/v, Isopropyl Alcohol 0.5%. Purpose: Antiseptic

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

237 mL NDC: 78185-010-01


Advanced Ingredient Data


Raw Label Data

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