KeraStat® Cream RX Package Insert

K192386 

610225 KeraNetics IFU KeraStat Cream K192386 VER.A PAGE 1 3.29.2021 

KeraStat® Cream
Wound Dressing Rx Only Manufactured For: KeraNetics Inc., Winston-Salem, NC 27101 USA 

PRODUCT DESCRIPTION 

KeraStat® Cream is a non-sterile, non-implantable wound dressing intended to provide a moist environment in the management of a variety of partial thickness dermal wounds. KeraStat® Cream is provided in a screw top tube. Each tube contains keratin protein incorporated into a cream base. 

INDICATIONS FOR USE 

KeraStat® Cream is intended to maintain a moist wound environment. KeraStat® Cream is indicated for the management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns, severe sunburns, superficial injuries, cuts, abrasions, and incisions/ 

® 

used in the management of dry, light, and moderately exuding partial thickness wounds including: pressure (stage I-II) ulcers, venous stasis ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, radiation dermatitis, donor sites, and grafts.
KeraStat® Cream is not indicated for full thickness or third degree burns. This device will be available by prescription. 

KeraStat® Cream is not indicated for full thickness or third degree burns. 

CAUTION 

WARNINGS / PRECAUTIONS 

In vitro analyses determined that an immune reagent used to detect Merkel cell carcinoma weakly reacts with the keratin in KeraStat® Cream. 

KeraStat® Cream should not be used on bleeding wounds until the bleeding has been stopped. Caution is advised on infected wounds. 

KeraStat® Cream should not be used on skin rashes related to food or medicine allergies or when an allergy to one of the ingredients is known. 

KeraStat® Cream should be applied at a frequency recommended by the physician. 

Contact a health care professional if (1) signs of infection occur (e.g., increased pain),(2) there is a change in wound color and/or odor, (3) the wound does not begin to show signs of healing, or (4) any other unexpected symptoms occur. 

® ophthalmic use. 

KeraStat® Cream should not be used on more than 10% of the total body surface area (TBSA) for children under 18 years. 

In radiation therapy, KeraStat® Cream may be applied as directed by the treating physician. Do not apply 4 hours prior to a radiation session. 

KeraStat® Cream may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated. 

Keep this and all similar products out of reach of children. 

KeraStat® is a registered trademark, and the product incorporates patented and/or patent pending  technologies owned by KeraNetics, Inc. Federal law restricts this device to sale by or on the order of a physician