# K120730: Loutrex Topical Cream

- Pathway: 510(k) (Traditional)
- Applicant: Acella Pharmaceuticals, LLC
- Decided: Sep 6, 2012 after 181 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.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050158: Sinclair Seborrhea Emulsion, Sinclair Pharmaceuticals, Ltd. (2006) Summary page 1.
- K111168: Precision Skin Emulsion, Precision Dermatology Incorporated (2011) Summary page 1.

## Most influential descendants
- K152945: Alevicyn SG Antipruritic Gel (2015), 3 descendants of its own
- K171935: Alevicyn SG Antimicrobial Gel (2017), 1 descendant of its own
- K173896: Microcyn Antimicrobial Hydrogel (2018), 0 descendants of its own
- K162217: LOYON (2017), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, Loutrex Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. Loutrex Topical Cream 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/K120730
Methodology: https://510kreport.com/methodology