Atopaderm Cream

Manufacturer
OnPace Pharma, LLC
Effective date
2018-11-15
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:47:09

Label at a glance#

ProductAtopaderm Cream
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS FOR USE

INDICATIONS & USAGE SECTION

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

DESCRIPTION SECTION

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

CONTRAINDICATIONS SECTION

Atopaderm Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

WARNINGS

WARNINGS SECTION

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

PRECAUTIONS SECTION

• 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

INSTRUCTIONS FOR USE SECTION

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

SPL UNCLASSIFIED SECTION

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

HOW SUPPLIED SECTION

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:

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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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72057-001-01GM - Gram72057-001a111601c-c09c-4402-b7b7-8fcfaee72f9012019-04-11

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72057-00172057-001-01

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.