NOVANA MOISTURIZING- dimethicone cream

Novana Moisturizing by

Drug Labeling and Warnings

Novana Moisturizing 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

Uses Helps to prevent and temporarily protect chafed, chapped, or cracked skin.

Warnings
When using this product Do not get into eyes. Stop use and ask doctor 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.

For external use only.

Inactive ingredients
Water, Lanolin Oil, Cod Liver Oil, Propylene Glycol, Polyethylene, Sodium Polyacrylate, Cetyl Alcohol, Beeswax, Glyceryl Stearate, Caprylic/Capric Triglyceride, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Sodium Laureth Sulfate, Diazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.

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

Directions
Apply as needed.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NOVANA MOISTURIZING 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76077-200
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)
Lanolin (UNII: 7EV65EAW6H)
Cod Liver Oil (UNII: BBL281NWFG)
Propylene Glycol (UNII: 6DC9Q167V3)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
Cetyl Alcohol (UNII: 936JST6JCN)
YELLOW WAX (UNII: 2ZA36H0S2V)
Glyceryl Monostearate (UNII: 230OU9XXE4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
Sodium Laureth Sulfate (UNII: BPV390UAP0)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76077-200-04	120 mL in 1 TUBE
2	NDC: 76077-200-07	210 mL in 1 TUBE
3	NDC: 76077-200-09	270 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	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