NOVANA WASH PERINEAL SKIN CLEANSER- benzethonium chloride solution

Novana Wash Perineal Skin Cleanser by

Drug Labeling and Warnings

Novana Wash Perineal Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by NOVANA MEDICAL LLC, O.L. PRODUCTS, INC. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                        Purpose
Benzethonium Chloride 0.1 %......................................................Antiseptic

PURPOSE

Uses For skin irritation due to incontinence. Protects against the risk of bacterial contamination in minor cuts, scrapes, and burns. Aids in the cleanup of urine and feces. Helps to remove barrier cream from skin.

WARNINGS

Warnings
For external use only.
When using this product Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask doctor if if skin irritation and redness develop.

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions Cleanse the affected area according to protocol.

INACTIVE INGREDIENT

Inactive ingredients Water, Sodium Laureth Sulfate, Polyquaternium-7, Phenoxyethanol, Iodopropynyl Butylcarbamate

DOSAGE & ADMINISTRATION

Protocol: Shake well before use. Cleansing: Spray on the affected perineal area and remove with a moist washcloth. Aids in the removal of urine, feces and other foreign material. Ostomyl/Incontinence Appliance: To help control odor, spray into appliance before and after use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NOVANA WASH PERINEAL SKIN CLEANSER 
benzethonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76077-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP)	Benzethonium Chloride	0.001 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium Laureth Sulfate (UNII: BPV390UAP0)
POLYQUATERNIUM-7 (76/24 ACRYLAMIDE/DADMAC; 120 KD) (UNII: AAJ238UT03)
Phenoxyethanol (UNII: HIE492ZZ3T)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76077-100-04	120 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/04/2012

Labeler - NOVANA MEDICAL LLC (964916600)

Registrant - O.L. PRODUCTS, INC. (961405883)

Establishment
Name	Address	ID/FEI	Business Operations
O.L. PRODUCTS, INC.		961405883	label, manufacture