# K024367: Sinclair Wound and Skin Emulsion

- Pathway: 510(k) (Traditional)
- Applicant: Sinclair Pharmaceuticals, Ltd.
- Decided: Jul 28, 2003 after 209 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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: 1 generation back to K961758 (1996). 2 ancestors in all.
67 later devices descend from it; 10 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964240: Biafine Wound Dressing Emulsion, Medix Pharmaceuticals Americas, Inc. (1997) Summary page 1.
- K961758: Carasyn Hydrogel Wound Products, Carrington Laboratories, Inc. (1996) Summary page 1.

## Most influential descendants
- K041342: Impruv a.I. Cream Wound and Skin Emulsion (2005), 44 descendants of its own
- K102945: Pediacyn Atopic Dermatitis Hydrogel (2011), 17 descendants of its own
- K052643: Epiceram (2006), 16 descendants of its own
- K123071: Vashe Skin and Wound Hydrogel (2013), 11 descendants of its own
- K141863: Puricore Wound Hydrogel Spray Dressing (2015), 10 descendants of its own

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

Source page: https://510kreport.com/device/K024367
Methodology: https://510kreport.com/methodology