Zenphor Wound Gel

Manufacturer
SA3, LLC
Effective date
2021-08-26
Label type
MEDICAL DEVICE
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:37:22

Label at a glance#

ProductZENPHOR WOUND
Label structure9 sections

Indications and uses

It is intended to provide a moist wound healing environment to facilitate the normal wound healing process.

Dosage and administration

Ensure that the wound area is clean. Apply the gel to the affected area as a very thin coat and allow it to dry. Apply once daily. How is ZENPHOR WOUND   GEL Supplied ZENPHOR WOUND   GEL  is supplied in: 30 gram bottle 69420-8004-1 Store at 20°-25°C (68° to 77°F); Keep away from heat and protect from freezing. [See USP Controlled Room Temperature.] Manufactured for:   SA3, LLC Los Angeles, CA 90064

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ZENPHOR WOUND GEL
SA3, LLC
-----------------------------

ZENPHOR WOUND GEL 
Rx only

For external use only

Not for ophthalmic use

Description

DESCRIPTION SECTION

ZENPHOR WOUND GEL 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.

ZENPHOR WOUND GEL is a self-drying, flexible, gas permeable, gel that is colorless and odorless. It is intended to provide a moist wound healing environment to facilitate the normal wound healing process.

INGREDIENTS

ZENPHOR WOUND GEL contains: Allantoin, Sulfadiazine, Aloe Vera Gel, Glycerol, Sodium Polyacrylate, Tartaric Acid, EDTA Disodium Salt, Hydroxyethyl Cellulose, Hyaluronic Acid, Hydrocotyle Asiatica Extract, and Pure Water.

INDICATIONS AND USES

INDICATIONS & USAGE SECTION

It is intended to provide a moist wound healing environment to facilitate the normal wound healing process.

Contraindications

CONTRAINDICATIONS SECTION

ZENPHOR WOUND GEL is contraindicated in patients with known hypersensitivity to any of the listed ingredients.

Warnings

WARNINGS SECTION

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

PRECAUTIONS SECTION

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

ADVERSE REACTIONS SECTION

On rare occasions, the gel may cause temporary redness, stinging, burning or irritation and normally disappear when the medication is discontinued.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Ensure that the wound area is clean. Apply the gel to the affected area as a very thin coat and allow it to dry. Apply once daily.

How is ZENPHOR WOUND GEL Supplied

ZENPHOR WOUND GEL is supplied in:
30 gram bottle
69420-8004-1

Store at 20°-25°C (68° to 77°F); Keep away from heat and protect from freezing. [See USP Controlled Room Temperature.]

Manufactured for: 
SA3, LLC
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZENPHOR WOUND GEL
69420-8004-1
30 gram
Rx Only

PRINCIPAL DISPLAY PANEL ZENPHOR WOUND GEL 69420-8004-1 30 gram Rx OnlyPRINCIPAL DISPLAY PANEL ZENPHOR WOUND GEL 69420-8004-1 30 gram Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69420-8004-1GM - Gram69420-8004873274fb-565e-4d42-8cfe-2d1fb60c34dd12022-03-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69420-800469420-8004-1

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.