BIO FRESH ANTIBACTERIAL HAND SANITIZER- ethanol gel

Bio Fresh Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Bio Fresh Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by KONEL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethanol 65% v/v

INACTIVE INGREDIENTS

Water, Glycerin, Methylcellulose, 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

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.

Other information

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIO FRESH ANTIBACTERIAL HAND SANITIZER 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71059-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
Ascorbic acid (UNII: PQ6CK8PD0R)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71059-060-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020

Labeler - KONEL (689605036)

Registrant - KONEL (689605036)

Establishment
Name	Address	ID/FEI	Business Operations
KONEL		689605036	manufacture(71059-060)