Search Results
Found 2 results
510(k) Data Aggregation
K Number
K123678Device Name
HYALMIX CREAM
Manufacturer
IGI LABORATORIES, INC.
Date Cleared
2013-12-16
(381 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
IGI LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, Hylamix 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. Hylamix Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Hylamix Cream is indicated for use in:
Atopic Dermatitis Allergic Contact Dermatitis Radiation Dermatitis
Device Description
Non-sterile, white, fragrance free, topical cream. Hylamix forms a physical barrier which maintains a moist wound and skin environment, and will be marketed in a 100 g tube, and 450 g jar as a prescription device.
Ask a Question
K Number
K123724Device Name
DERMISEB CREAM
Manufacturer
IGI LABORATORIES, INC.
Date Cleared
2013-08-28
(267 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
IGI LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, Dermiseb Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Dermiseb Cream also aids to relieve dry, waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.
Dermiseb Cream in indicated for use in:
- Seborrhea
- Seborrheic Dermatitis
Device Description
Non-sterile, off-white to slight pale-yellow colored, low odor, steroid-free, fragrance free, topical cream. Dermiseb Cream forms a physical barrier to relieve dry waxy skin by maintaining a moist wound and skin environment, and will be marketed in a 30 g tube as a prescription device.
Ask a Question
Page 1 of 1