PROANDRE- benzalkonium chloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

PROANDRE, SL

INN (International Name):

BENZALKONIUM CHLORIDE

Composition:

BENZALKONIUM CHLORIDE 0.1 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Active Ingredient Purpose Benzalkonium Chloride 0.1%....................Antibacterial Uses * Helps to eliminate bacteria on hands. Avoid contact with broken skin * Wash for 15-20 seconds * Rinse and dry hands thoroughly. * Children under 6 years of age should be supervised by an adult when using this product * Helps to eliminate bacteria on hands. Avoid contact with broken skin * Irritation and redness develops.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PROANDRE- BENZALKONIUM CHLORIDE LIQUID
PROANDRE, SL
_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._
----------
ACTIVE INGREDIENT PURPOSE
ACTIVE INGREDIENT PURPOSE
Benzalkonium Chloride 0.1%....................Antibacterial
US ES
US ES
* Helps to eliminate bacteria on hands. Avoid
contact with broken skin
DIRECTIONS
* Wash for 15-20 seconds
* Rinse and dry hands thoroughly.
* Children under 6 years of age should be
supervised by an adult when using this product
US ES
* Helps to eliminate bacteria on hands. Avoid
contact with broken skin
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT:
* Avoid contact with face, eyes and broken skin
if eyes contact occurs, flush thoroughly with water
and seek medical advice.
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT:
* Avoid contact with face, eyes and broken skin
if eyes contact occurs, flush thoroughly with water
and seek medical advice.
STOP USE AND ASK DOCTOR IF
* Irritation and redness develops.
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or
contact a Poison Control Center
right away.
QUES TIONS ?.
+ 1 [phone]
DOSSAGE AND ADMINISTRATION
* Wash for 15-20 seconds
* Rinse and dry hands thoroughly.
* Children under 6 years of age should be
supervised by an adult when using this product
INACTIVE INGREDIENTS
Water, Cocamidopropylbetaine, sodium chloride,
potassium sorbate, sodium benzoate, citric acid,
FD&C Yellow 5, FD&C Red 40.
ANTIBACTERIAL ANTIBACT SOAP LIQUID
ANTIBACTERIAL ANTIBACT SOAP LIQUID
Fragrance free
PROANDRE
benzalkonium chloride liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 0 28 -0 0 2
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6 JUD5X6 Y)
BENZALKONIUM
CHLORIDE
0 .1 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT N