Drug Facts

NOVANA MOISTURIZING - dimethicone cream
NOVANA MEDICAL LLC

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.

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Drug Facts

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.

NOVANA MOISTURIZING
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76077-200
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/04/2012

Labeler - NOVANA MEDICAL LLC (964916600)

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

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