PURFREE HAND SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

STERILCO SP Z O O

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic, Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available. -on children less than 2 months of age. -on open skin wounds. Stop using and ask a doctor if irritation or redness develops and lasts.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PURFREE HAND SANITIZER- ALCOHOL GEL
STERILCO SP Z O O
_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._
----------
HAND SANITISER PURFREE
Alcohol 75% v/v. Purpose: Antiseptic
Antiseptic, Hand Sanitizer
to help reduce bacteria on the skin. For use when soap and water are
not available.
For external use only. Flammable. Keep away from sources of heat or
fire.
-on children less than 2 months of age.
-on open skin wounds.
Avoid contact with eyes. If contact occurs, rinse thoroughly with
water.
Stop using and ask a doctor if irritation or redness develops and
lasts.
Keep out of reach of children.
In case of accidental ingestion, get medical help or contact a Poison
Control Center
immediately.
-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.
-store at a temperature below 110°F (43°C).
-may discolor certain fabrics and surfaces.
water, Glycerin, Propylene Glycol, Menthol, Carbomer, Aminomethyl
Propanol.
PURFREE HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
STERILCO SP Z O O
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
CAT