BIO FRESH ANTIBACTERIAL HAND SANITIZER- ethanol spray 
KONEL

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

Ethanol 65% v/v

INACTIVE INGREDIENTS

Water, Glycerin, Propolis, Citric Extractives, Ascorbic acid, Lactic acid, Citric acid

PURPOSE

ANTISEPTIC

WARNINGS

For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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.

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

• Spray 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.

Other information

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

BIO FRESH ANTIBACTERIAL HAND SANITIZER 
ethanol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71059-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
Ascorbic acid (UNII: PQ6CK8PD0R)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71059-050-01500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - KONEL (689605036)
Registrant - KONEL (689605036)
Establishment
NameAddressID/FEIBusiness Operations
KONEL689605036manufacture(71059-050)

Revised: 6/2020
Document Id: bab84c14-7dc3-4380-9d65-7bf04a3615ea
Set id: 4fb3a18d-9e57-4571-a539-e6e1d1aa53a7
Version: 1
Effective Time: 20200612
 
KONEL