DEODERM: Package Insert and Label Information

DEODERM-
LIFSA DRUG LLC

DESCRIPTION

Deoderm Gel is a soothing wound gel that is formulated for the dressing and management of superficial wounds, minor abrasions, pressure ulcers stage II — IV, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound hyaluronic acid adheres to tissue to prevent damage while supplying moisture to the cells. Medium molecular weight polysaccharides in aloe vera moisturize and reduce inflammation. Proven therapeutic moisturizers, lipids, glycerin and allantoin, relieves dryness.

Deoderm Gel is a non-sterile, off-white, low odor, fragrance free, topical product. The Deoderm Gel forms a physical barrier that helps to maintain a moist wound and skin environment. Deoderm Gel is a prescription medical device.

INDICATIONS FOR USE

Under the supervision of a healthcare professional, Deoderm Gel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Deoderm Gel also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS

Deoderm Gel is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

WARNINGS

Use only as directed. Keep out of the reach of children. Avoid contact with eyes. For topical use only. Not for ophthalmic use. Do not apply within four hours prior to a radiation session.

PRECAUTIONS AND OBSERVATIONS

  • Deoderm Gel does not contain a sunscreen and should not be used prior to extended exposure to the sun.
  • If clinical signs of infection are present, appropriate treatment should be initiated; use of Deoderm Gel may be continued during the anti-infective therapy.

INSTRUCTIONS FOR USE

Dispense Deoderm Gel into palm of hand and apply to affected area 3 times per day, or as directed by a physician. Massage gently into the skin until completely absorbed. If the skin is broken, cover with appropriate dressing Deoderm Gel is non-sterile.

INGREDIENTS

Allantoin
Aloe Barbadensis Leaf Extract
Caprylic/Capric Triglyceride
Carbomer
Ceteareth 20
Cetearyl Alcohol
Diazolidinyl Urea & Iodopropynyl Butylcarbamate
Dimethicone
Glycerin
Glycol Stearate
Hyaluronic Acid
Isopropyl Palmitate
Olea Europaea (Olive) Oil
Propylene Glycol
Tetrasodium EDTA
Triethanolamine
Water

HOW SUPPLIED

Deoderm Gel is available in 30g commercial pump dispenser.


CAUTION: Federal law restricts this device to sale by or on the order of a physician or other licensed health care practitioner.


Store between 59°F — 86°F (15°C — 30°C).

MANUFACTURED FOR:

Lifsa Drugs LLCNew Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL

DEODERM GEL

NET WEIGHT: 30G

NDC: 72336-054-01

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DEODERM
Product Information
Product Type Item Code (Source) NHRIC:72336-054
Inactive Ingredients
Ingredient Name Strength
WATER
ALOE VERA LEAF
GLYCERIN
OLIVE OIL
MEDIUM-CHAIN TRIGLYCERIDES
DIMETHICONE
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
HYALURONIC ACID
GLYCOL STEARATE
PROPYLENE GLYCOL
ALLANTOIN
ISOPROPYL PALMITATE
TROLAMINE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
DIAZOLIDINYL UREA
IODOPROPYNYL BUTYLCARBAMATE
EDETATE SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:72336-054-01 30 g in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
exempt device MDA 06/12/2020
Labeler — LIFSA DRUG LLC (081205160)

Revised: 06/2020 LIFSA DRUG LLC

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