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Proandre by PROANDRE, SL

Medically reviewed on November 25, 2016

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 0.1mg in 1mL
Labeler: PROANDRE, SL
NDC Code: 70028-002

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

Uses

Uses

* 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

Uses

* 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.

Questions?.

+ 1 (305) 961 1156

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:70028-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER80.079 mg  in 1 mL
COCAMIDOPROPYL BETAINE18.1 mg  in 1 mL
SODIUM CHLORIDE0.9 mg  in 1 mL
POTASSIUM SORBATE0.3 mg  in 1 mL
SODIUM BENZOATE0.3 mg  in 1 mL
ANHYDROUS CITRIC ACID0.02 mg  in 1 mL
FD&C YELLOW NO. 50.0005 mg  in 1 mL
FD&C RED NO. 400.0005 mg  in 1 mL
Packaging
#Item CodePackage Description
1NDC:70028-002-01800 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/20/2015
Labeler - PROANDRE, SL (463207675)
Registrant - PROANDRE, SL (463207675)
Establishment
NameAddressID/FEIOperations
PROANDRE, SL463207675manufacture(70028-002)

 
PROANDRE, SL

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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