# K082089: Prumyx Cream

- Pathway: 510(k) (Traditional)
- Applicant: Prugen, Inc.
- Decided: Jan 13, 2009 after 173 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K961758 (1996). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041342: Impruv a.I. Cream Wound and Skin Emulsion, Stiefel Laboratories, Inc. (2005) Summary page 1.

## Most influential descendants
- K110172: Sonafine Wound Dressing (2011), 2 descendants of its own
- K233151: PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) (2024), 0 descendants of its own
- K140905: Dermafine (2015), 0 descendants of its own

## Indications for use
FOR TOPICAL DERMATOLOGICAL USE ONLY Description Rx Product: Under the supervision of a healthcare professional, PruMyx Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. PruMyx Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Directions for Use (Rx and OTC): Apply PruMyx Cream to the affected skin areas 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover PruMyx Cream with a dressing of choice. Description OTC Product: PruMyx Cream helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. PruMyx Cream may also be used to soothe minor bums, including sunburn.

Source page: https://510kreport.com/device/K082089
Methodology: https://510kreport.com/methodology