LORO HAND SANITIZER- ethyl alcohol 70% gel

LORO Hand Sanitizer by

Drug Labeling and Warnings

LORO Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sun Hing Foods Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

1. 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.
2. Isopropyl Alcohol (0.2% v/v)
3. Glycerol (0.25% v/v).
4. Acrylite Crosspolymer (0.5% v/v).
5. Ginger Oil (0.05% v/v).
6. 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.

Active Ingredient(s)

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

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

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

Do not use

• Children under 6 years of age should be supervised when using LORO.

WHEN USING

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.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other information

• Store below 110 Degree F (43 Degree C)
• May discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Acrylige Crosspolymer, Glycerin, Ginger OIl.

Package Label - Principal Display Panel

5000 mL NDC: 78185-013-01

INGREDIENTS AND APPEARANCE

LORO HAND SANITIZER 
ethyl alcohol 70% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78185-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.2 mL  in 5000 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 5000 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)	0.5 mL  in 5000 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.25 mL  in 5000 mL
WATER (UNII: 059QF0KO0R)	29 mL  in 5000 mL
GINGER OIL (UNII: SAS9Z1SVUK)	0.05 mL  in 5000 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78185-013-01	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Sun Hing Foods Inc (066460726)