ZENPHOR WOUND PAD- zenphor patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Available from:

Beijing HKKY Medical Tech. Co., Ltd.

Administration route:

TOPICAL

Therapeutic indications:

It is intended to provide a moist wound healing environment to facilitate the normal wound healing process. ZENPHOR WOUND PAD is contraindicated in patients with known hypersensitivity to any of the listed ingredients.

Authorization status:

Exempt device

Summary of Product characteristics

ZENPHOR WOUND PAD- ELASTOMER, SILICONE, FOR SCAR MANAGEMENT PATCH
BEIJING HKKY MEDICAL TECH. CO., LTD.
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71073_212_ZENPHOR WOUND PAD
DESCRIPTION
ZENPHOR WOUND PAD is a non-sterile nonresorbable occlusive wound
dressing
intended to cover a wound, to provide or support a moist wound
environment, and to
allow the exchange of gases such as oxygen and water vapor through the
device. It
consists of a piece of synthetic polymeric material with an adhesive
backing. This
classification does not include an occlusive wound dressing that
contains added drugs
such as antimicrobial agents, added biologics such as growth factors,
or is composed of
materials derived from animal sources.
Each ZENPHOR WOUND PAD contains: Urea, Phenyl Trimethicone, Aloe Vera
Gel,
Glycerol, Sodium Polyacrylate, Tartaric Acid, EDTA Disodium Salt,
Polyacrylic Acid,
Hyaluronic Acid, Hydrocotyle Asiatica Extract, and Water.
INDICATIONS AND USES
It is intended to provide a moist wound healing environment to
facilitate the normal
wound healing process.
CONTRAINDICATIONS
ZENPHOR WOUND PAD is contraindicated in patients with known
hypersensitivity to
any of the listed ingredients.
WARNINGS
For external use only. If irritation occurs, discontinue use and
consult your physician.​ ​Do
not use in patients with known hypersensitivity to any of the listed
ingredients.​ ​Store at
20°-25°C (68° to 77°F); Keep away from heat and protect from
freezing. [See USP
Controlled Room Temperature.]
​KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN​
PRECAUTIONS
Stop use and ask a doctor if irritation develops. In rare instances,
silicone sheets may
cause a rash on the skin. If ingested, get medical help or contact
Poison Control Center
right away.
This medication should be used as directed by your physician during
pregnancy or while
breastfeeding. Consult your doctor about the risks and benefits.
CAUTION: Federal law restricts this device to sale by or on the order
of a physician.
ADVERSE REACTIONS
On rare occasions, the pads may cause temporary redness