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

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

Product2

PROANDRE 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70028-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 80.079 mg  in 1 mL
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 18.1 mg  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.9 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.3 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.3 mg  in 1 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.02 mg  in 1 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.0005 mg  in 1 mL
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.0005 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70028-002-01800 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/26/2015
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/FEIBusiness Operations
PROANDRE, SL463207675manufacture(70028-002)

Revised: 11/2016
Document Id: 4228b14d-910c-7073-e054-00144ff88e88
Set id: 1dca08ce-3df0-0203-e054-00144ff88e88
Version: 2
Effective Time: 20161125
 
PROANDRE, SL