PROANDRE- benzalkonium chloride liquid

Proandre by

Drug Labeling and Warnings

Proandre by is a Otc medication manufactured, distributed, or labeled by PROANDRE, SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PROANDRE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70028-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70028-002-01	800 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/26/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/20/2015

Labeler - PROANDRE, SL (463207675)

Registrant - PROANDRE, SL (463207675)

Establishment
Name	Address	ID/FEI	Business Operations
PROANDRE, SL		463207675	manufacture(70028-002)