RevitaDERM Wound Care

Benzalkonium Chloride · Gel · Topical

Over the counter 2 recalls

Active ingredient

Active Ingredients Active Ingredients Benzalkonium Chloride (0.1%)

Purpose

Purpose Purpose Antimicrobial

Uses

Uses Uses * 1st and 2nd Degree Burns * Stasis Ulcers * Pressure Ulcers * Diabetic Ulcers * Lacerations * Abrasions * Skin Tears * Surgical Incision Sites * Device Insertion Sites * Graft Sites * Donor Sites

Warnings

Warnings Warnings For external use only.

Ask a doctor before use

Ask a doctor before use Ask a doctor before use RevitaDERM Wound Care Gel is for external use only. Avoid contact with eyes. If you get it in your eyes, rinse immediately with cool tap water. RevitaDERM Wound Care Gel may become discolored when it mixes with fluid from the wound. This is normal and not a cause for concern. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor. Talk with your doctor before you use any other medicines or cleansers on your skin. RevitaDERM Wound Care Gel does not contain sunscreen. Ask you doctor before you use RevitaDERM Wound Care Gel if you must be outside for a long period of time. If your symptoms do not get better or if they get worse, check with your doctor.

Keep out of reach of children

Keep Out Of Reach Of Children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions Directions Evenly apply RevitaDERM Wound Care approximately 1/8 inch to 1/4 inch thick to the wound area. Cover wound with appropriate dressing. Repeat as necessary to keep the wound moist.

Inactive ingredients

Inactive Ingredients Inactive ingredients Aloe Barbadensis (Aloe) Leaf Juice, Aloe Barbadensis (Aloe) oil extract, Carbomer, Collagen, Elastin, Glycerin, Hyaluronic Acid, Triethanolamine, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben.

Label text from the FDA structured product label by Blaine Labs Inc. (revised Dec 21, 2023). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

RevitaDERM Wound Care NDC products (1)

NDCStrength & formLabelerType
63347-120Benzalkonium Chloride 170 mg/89mL
Gel
Blaine Labs Inc.OTC MONOGRAPH DRUG

RevitaDERM Wound Care recalls

Frequently asked questions

What is RevitaDERM Wound Care used for?

Uses Uses * 1st and 2nd Degree Burns * Stasis Ulcers * Pressure Ulcers * Diabetic Ulcers * Lacerations * Abrasions * Skin Tears * Surgical Incision Sites * Device Insertion Sites * Graft Sites * Donor Sites

Who makes RevitaDERM Wound Care?

RevitaDERM Wound Care is listed by 1 labeler in the FDA NDC directory, including Blaine Labs Inc..

Has RevitaDERM Wound Care been recalled?

The FDA enforcement database lists 2 recalls for RevitaDERM Wound Care, most recently D-0699-2026 (class ii): CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated