# K090337: Tropazone Lotion

- Pathway: 510(k) (Traditional)
- Applicant: Midlothian Laboratories
- Decided: Aug 13, 2009 after 184 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: 4 generations back to K961758 (1996). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 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.
- K073246: Zenieva, Gorbec Pharmaceutical Services, Inc. (2008) Summary page 1.
- K964240: Biafine Wound Dressing Emulsion, Medix Pharmaceuticals Americas, Inc. (1997) Summary page 1.

## Most influential descendants
- K093544: Tropazone CR (2010), 1 descendant of its own
- K162217: LOYON (2017), 0 descendants of its own
- K113807: Dexeryl Cream (2012), 0 descendants of its own

## Indications for use
Tropazone Lotion is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. It helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Source page: https://510kreport.com/device/K090337
Methodology: https://510kreport.com/methodology