Emulsion SB by PruGen, Inc. EMULSION SB-

Emulsion SB by

Drug Labeling and Warnings

Emulsion SB by is a Other medication manufactured, distributed, or labeled by PruGen, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Emulsion SB is a steroid-free, fragrance-free, ceramide formulation.

INDICATIONS & USAGE

Emulsion SB is to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. Emulsion SB helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS

Emulsion SB is contraindicated in persons with known hypersensitivity to any of the components of the formulation.

WARNINGS

Emulsion SB does not contain a sunscreen and should always be used in conjunction with a sunscreen in sun exposed areas

Do not apply within 4 hours prior to radiation therapy

Keep this and similar products out of the reach of children

Follow directions for use

If condition does not improve within 10 to 14 days, consult physician

PRECAUTIONS AND OBSERVATIONS

For the treatment of any dermal wound, consult a physician.

Use Emulsion SB only as directed

Emulsion SB is for external use only and should not be ingested or taken internally

If clinical signs of infection are present, appropriate treatment should be initiated. If clinically indicated, use of Emulsion SB may be continued during the anti-infective therapy

In radiation dermatitis and/or in conjunction with ongoing radiation therapy, apply following radiation therapy or as indicated by the radiation therapist

INSTRUCTIONS FOR USE

Apply a thin layer to the affected skin areas 2 times per day (or as needed or directed by your physician) and massage gently into the skin. If the skin is broken, cover Emulsion SB with a dressing of choice.

INGREDIENTS

Capric Acid, Cholesterol, Citric Acid, Conjugated Linoleic Acid, Dimethicone, Disodium EDTA, E. Cerifera (Candelilla) Wax, Food Starch Modified Corn Syrup Solids, Glycerin, Glyceryl Stearate, Hydroxypropyl Bispalmitamide MEA (Ceramide), Palmitic Acid, PEG-100 Stearate, Petrolatum, Phenoxyethanol, Potassium Hydroxide, Purified Water, Sorbic Acid, Squalane, Xanthan Gum.

HOW SUPPLIED

Emulsion SB is supplied as follows:

NDC: 42546-155-90: 90 gram tube

NDC: 42546-155-50: 50 gram tube

NDC: 42546-155-52: Package contains two 50 gram tubes

Store at 15ºC to 30ºC (59ºF to 86ºF). Do not freeze.

Rx ONLY - Prescription Medical Device; Federal Law restricts this device to sale by or on the order of a physician.

Manufactured for:

PruGen, Inc. Pharmaceuticals

8714 E Vista Bonita Dr

Scottsdale, AZ 85255

Emulsion SB Carton Label

NDC: 42546-155-90

Emulsion SB Topical Emulsion

Rx Only

90g

PruGen, Inc. Pharmaceuticals

INGREDIENTS AND APPEARANCE

EMULSION SB 
dressing, wound, drug

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:42546-155

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:42546-155-90	1 in 1 BOX
1		90 g in 1 TUBE
2	NHRIC:42546-155-50	1 in 1 BOX
2		50 g in 1 TUBE
3	NHRIC:42546-155-52	2 in 1 BOX
3		50 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K110732	05/05/2011

Labeler - PruGen, Inc. (929922750)