Atopaderm Cream by OnPace Pharma, LLC ATOPADERM CREAM-

Atopaderm Cream by

Drug Labeling and Warnings

Atopaderm Cream by is a Other medication manufactured, distributed, or labeled by OnPace Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS FOR USE

Under the supervision of a healthcare professional, Atopaderm Cream 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. Atopaderm Cream also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

DEVICE DESCRIPTION

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

CONTRAINDICATIONS

Atopaderm Cream 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

Atopaderm Cream 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 Atopaderm Cream may be continued during the anti-infective therapy.
If the condition does not improve within 10-14 days, consult a physician.
Atopaderm Cream may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.

INSTRUCTIONS FOR USE

Dispense Atopaderm Cream 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. Atopaderm Cream is non-sterile.

INGREDIENTS

Water, Glycerin, Ethylhexyl Palmitate, Cetearyl Alcohol, Propylene Glycol, Dicetyl Phosphate, Theobroma Grandiflorum Seed Butter, Petrolatum, Dimethicone, Steareth-10, Ceteareth-10 Phosphate, Hydroxypropyl Bispalmitamide MEA (Ceramide), Tocopheryl Acetate, Methylparaben, Disodium EDTA, Propylparaben, Sodium Hyaluronate and Sodium Hydroxide.

HOW SUPPLIED

Atopaderm Cream is available in 100g commercial tubes.

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).

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR:

OnPace Pharma, LLC
996 N HALSTEAD RD STE B
OCEAN SPRINGS MS 39564
(228) 207-8112
www.onpacepharma.com

Atopaderm Cream Net Weight: 100gNDC:

72057-001-01

INGREDIENTS AND APPEARANCE

ATOPADERM CREAM 
cream, nasal, topical, mechanical allergen particle barrier

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:72057-001

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:72057-001-01	1 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K150914	03/26/2018

Labeler - OnPace Pharma, LLC (081039213)