PURFREE HAND SANITIZER- alcohol gel

PurFree Hand Sanitizer by

Drug Labeling and Warnings

PurFree Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by STERILCO SP Z O O. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 75% v/v. Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

to help reduce bacteria on the skin. For use when soap and water are not available.

WARNINGS

For external use only. Flammable. Keep away from sources of heat or fire.

DO NOT USE

-on children less than 2 months of age.
-on open skin wounds.

WHEN USING

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

STOP USE

Stop using and ask a doctor if irritation or redness develops and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

-put enough product in your palm to cover hands and rub hands together until dry.
-children under 6 years old should be supervised when using this product.

STORAGE AND HANDLING

-store at a temperature below 110°F (43°C).
-may discolor certain fabrics and surfaces.

INACTIVE INGREDIENT

water, Glycerin, Propylene Glycol, Menthol, Carbomer, Aminomethyl Propanol.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURFREE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78717-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78717-001-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020
2	NDC: 78717-001-02	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/27/2020

Labeler - STERILCO SP Z O O (851443421)

Establishment
Name	Address	ID/FEI	Business Operations
STERILCO SP Z O O		851443421	manufacture(78717-001)