Neosalus Cream

GUDID 00381811000008

NEOSALUS Cream is a fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Cream is intended for topical application.

Resilia Pharmaceuticals, Inc.

Dry skin moisture barrier dressing

• Primary Device ID: 00381811000008
• NIH Device Record Key: cd91d319-d952-40b9-acca-6b39f1562472
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neosalus Cream
• Version Model Number: 1
• Company DUNS: 117711487
• Company Name: Resilia Pharmaceuticals, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com
• Phone: 404-446-1391
• Email: mleone@resiliapharma.com

Device Dimensions

• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381811000008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090585

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-21
• Device Publish Date: 2024-06-13

Devices Manufactured by Resilia Pharmaceuticals, Inc.

• 00381811000008 - Neosalus Cream: 2024-06-21NEOSALUS Cream is a fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Cream is intended for topical application.
• 00381811000008 - Neosalus Cream: 2024-06-21 NEOSALUS Cream is a fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses includin
• 00381811000022 - Neosalus Lotion: 2024-06-21 NEOSALUS Lotion is a fragrance-free, water-soluble dressing formulated for the management and relief of irritation experienced w
• 00381811000060 - Recedo Topical Gel: 2024-06-20 Recedo Topical Gel is an advanced formula scar gel intended for the management of old and new hypertrophic or keloid scarring re