NOVANA ALL-IN-ONE ONE STEP PERINEAL- dimethicone lotion

Novana All-In-One One Step Perineal by

Drug Labeling and Warnings

Novana All-In-One One Step Perineal 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
Dimethicone 2%.......................................................................................................Skin Protectant

PURPOSE

Uses Temporarily protects and helps relieve chapped or cracked skin.

WARNINGS

Warnings
For external use only.
When using this product Avoid contact with eyes Stop use and ask doctor if  If condition worsens  symptoms last more than 7 days or clear up and occur again within a few days. Do not use on  deep or puncture wounds  animal bites  serious burns.

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

For external use only.

INDICATIONS & USAGE

Directions Apply as needed. Change wet and soiled undergarments. Apply to affected area and gently wipe with clean, soft cloth. Use with each undergarment change, especially at bedtime or any time when exposure to wet garments may be prolonged.

INACTIVE INGREDIENT

Inactive ingredients
Water, Cetyl Alcohol, Stearyl Alcohol, Glycine Soja (Soybean) Oil, Propanediol, Polysorbate 60,
Panthenol, Glycerin, Isopropyl Myristate, Allantoin, Tocopherol, Sodium Laureth Sulfate, Citric Acid,
Phenoxyethanol, Iodopropynyl Butylcarbamate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NOVANA ALL-IN-ONE ONE STEP PERINEAL 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76077-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	.02 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetyl Alcohol (UNII: 936JST6JCN)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Soybean Oil (UNII: 241ATL177A)
Propanediol (UNII: 5965N8W85T)
Polysorbate 60 (UNII: CAL22UVI4M)
Panthenol (UNII: WV9CM0O67Z)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Allantoin (UNII: 344S277G0Z)
Tocopherol (UNII: R0ZB2556P8)
Sodium Laureth Sulfate (UNII: BPV390UAP0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Phenoxyethanol (UNII: HIE492ZZ3T)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76077-500-08	240 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	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