LORO HAND SANITIZER- ethyl alcohol 70% spray 
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.

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LORO
HAND SANITIZER
Anti-Bacterial Spray
ETHYL ALCOHOL 70%
4 FL OZ (118mL)

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 (0.5% v/v).
  3. Grycerin (0.45% v/v).
  4. Ginger Oil (0.05% v/v).
  5. 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

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 appears and lasts.

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

Directions

Other information

Inactive ingredients

Water (Aqua), Glycerin, Ginger Oil.

Package Label - Principal Display Panel

118mL118 mL NDC: 78185-014-01

LORO HAND SANITIZER 
ethyl alcohol 70% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78185-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 118 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.5 mL  in 118 mL
Inactive Ingredients
Ingredient NameStrength
GINGER OIL (UNII: SAS9Z1SVUK) 0.05 mL  in 118 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.45 mL  in 118 mL
WATER (UNII: 059QF0KO0R) 29 mL  in 118 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78185-014-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Sun Hing Foods Inc (066460726)

Revised: 3/2020
Document Id: ae373c73-2b1b-28ca-e053-2995a90a452c
Set id: ae373520-b83d-4144-e053-2a95a90a7653
Version: 16
Effective Time: 20200330
 
Sun Hing Foods Inc