Loro

Loro
SPL v17
SPL
SPL Set ID ae37eaf2-98f2-af4c-e053-2995a90add37
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (0.45 mL) Alcohol (29 mL)
Inactive Ingredients
Glycerin Water Ginger Oil

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) (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. Isopropyl Alcohol (0.5% v/v). Glycerin (0.45% v/v). Ginger Oil (0.05% v/v). Water (29% 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.

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) (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. Isopropyl Alcohol (0.5% v/v). Glycerin (0.45% v/v). Ginger Oil (0.05% v/v). Water (29% 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.
  • Isopropyl Alcohol (0.5% v/v).
  • Glycerin (0.45% v/v).
  • Ginger Oil (0.05% v/v).
  • Water (29% 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 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

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

Directions
  • Place enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using LORO.
Do Not Use
  • Children 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.
Active Ingredient(s)

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

Inactive Ingredients

Water (Aqua), Glycerin, Ginger Oil.

Package Label Principal Display Panel

5000 mL NDC: 78185-015-01

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) (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.
  • Isopropyl Alcohol (0.5% v/v).
  • Glycerin (0.45% v/v).
  • Ginger Oil (0.05% v/v).
  • Water (29% 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 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

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

Directions
  • Place enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using LORO.
Do Not Use (Do not use)
  • Children 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.
Active Ingredient(s)

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

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Ginger Oil.

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

5000 mL NDC: 78185-015-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:37.064631 · Updated: 2026-03-14T22:58:14.813588