# K113807: Dexeryl Cream

- Pathway: 510(k) (Traditional)
- Applicant: Pierre Fabre Medical Devices
- Decided: Mar 7, 2012 after 75 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: 6 generations back to K961758 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093544: Tropazone CR, Midlothian Laboratories (2010) Summary page 1.
- K090585: Neosalus Cream, Quinnova Pharmaceuticals (2009) Summary page 1.
- K071483: Tetrix Cream, Coria Laboratories, Ltd. (2008) Summary page 1.
- K052643: Epiceram, Ceragenix Corporation (2006) Summary page 1.
- K964240: Biafine Wound Dressing Emulsion, Medix Pharmaceuticals Americas, Inc. (1997) Summary page 1.

## Indications for use
DEXERYLTM Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. DEXERYLTM Cream provides a moist environment, which is beneficial to the healing process.

Source page: https://510kreport.com/device/K113807
Methodology: https://510kreport.com/methodology