Atopaderm Cream

Basic Information

• Brand Name: Atopaderm Cream
• Primary DI: 00372057001010
• Version / Model: 101-001
• Company Name: ONPACE PHARMA LLC
• Labeler DUNS: 081039213
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-21
• Public Version: 3
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: e111de34-30e4-4d7a-9b1f-5878dcecf04f
• Distribution End Date: 2022-01-31

Device Description

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 Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46206	Dry skin moisture barrier dressing	A substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00372057001010	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150914	000

Device Sizes

Type	Value	Unit	Text
Weight	100	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius