BOURBON VANILLA HAND SANITIZER- alcohol gel 
Gold Orient International Limited

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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Active Ingredient(s)

Alcohol Denat 80% v/v.

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that could 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

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Blue 1, Red 40

Package Label - Principal Display Panel

label

BOURBON VANILLA HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51522-012
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51522-012-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Gold Orient International Limited (679905914)
Establishment
NameAddressID/FEIBusiness Operations
Gold Orient International Limited679905914manufacture(51522-012)

Revised: 6/2020
Document Id: a849a2e7-94a5-320d-e053-2a95a90ab24b
Set id: a849a2e7-94b3-320d-e053-2a95a90ab24b
Version: 1
Effective Time: 20200617
 
Gold Orient International Limited