Hand Sanitizer with Denatonium-Denatured Ethanol

Hand Sanitizer DB by

Drug Labeling and Warnings

Hand Sanitizer DB by is a Otc medication manufactured, distributed, or labeled by Phibro Animal Health Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER DB- alcohol liquid 
Phibro Animal Health Corporation

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 with Denatonium-Denatured Ethanol

Ethyl Alcohol 70% v/vEthyl Alcohol 70% v/v

Antiseptic

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

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


in children less than 2 months of age
on open skin wounds

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.


Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.


Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Denatonium Benzoate, Hyaluronic Acid, Carbopol SF-1 Co-formulants, 2-Amino-2-methyl-1-propanol, Fragrance, Acrylates, purified water USP

Package label

HAND SANITIZER DB 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66104-1157
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 24.6 mL  in 100 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 10 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 5 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.2 mL  in 100 mL
HYALURONIC ACID (UNII: S270N0TRQY) 0.1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66104-1157-0946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/11/202007/15/2021
Labeler - Phibro Animal Health Corporation (006989008)
Registrant - Phibro Animal Health Corporation (080154345)
Establishment
NameAddressID/FEIBusiness Operations
Phibro Animal Health Corporation080154345manufacture(66104-1157)

Revised: 9/2022
Document Id: e8be12c5-c590-eadd-e053-2a95a90a431b
Set id: ab85d92c-737f-a8be-e053-2995a90a5a14
Version: 2
Effective Time: 20220915