LORO Hand Sanitizer: Package Insert and Label Information

LORO HAND SANITIZER- isopropyl alcohol and alcohol gel
Sun Hing Foods Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 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 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.

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

5000mL
(click image for full-size original)

LORO HAND SANITIZER
ethyl alcohol 70% gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78185-013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.2 mL in 5000 mL
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 5000 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 0.5 mL in 5000 mL
GLYCERIN 0.25 mL in 5000 mL
WATER 29 mL in 5000 mL
GINGER OIL 0.05 mL in 5000 mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78185-013-01 5000 mL in 1 BOTTLE None
Image of Product
(click image for full-size original)
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)

Revised: 03/2020 Sun Hing Foods Inc

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