HAND SANITIZER- alcohol spray 
LaJoye Cellars

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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Hand Sanitizer

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

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.

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

Other information

Inactive ingredients

GLYCERIN PDC6A3C0OX 1.45 mL

HYDROGEN PEROXIDE BBX060AN9V 0.125 mL
LINALOOL, (+/-)- D81QY6I88E
ORANGE OIL AKN3KSD11B
CITRUS RETICULATA FRUIT OIL 25P9H3QU5E
WATER 059QF0KO0R

PackageLabel Principal Display Panel

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)

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.
  5. LINALOOL, (+/-)- D81QY6I88E
  6. ORANGE OIL AKN3KSD11B
  7. CITRUS RETICULATA FRUIT OIL 25P9H3QU5E

Package Label - Principal Display Panel

100 ML100ML NDC#79523-001-01

HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79523-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
ORANGE OIL (UNII: AKN3KSD11B)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79523-001-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - LaJoye Cellars (047352440)
Registrant - LAJOYE CELLARS (047352440)
Establishment
NameAddressID/FEIBusiness Operations
LAJOYE CELLARS047352440manufacture(79523-001)

Revised: 12/2020
Document Id: b6322aee-ef0d-d270-e053-2a95a90a4cb9
Set id: a9fa10bc-5681-2e88-e053-2a95a90a20cd
Version: 2
Effective Time: 20201211
 
LaJoye Cellars