Active Ingredients
Active Ingredients
Benzalkonium Chloride (0.1%)
Revitaderm Wound Care Gel
FDA Label NDC 63347-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blaine Labs Inc. for the product Revitaderm Wound Care (NDC 63347-120). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, keep out of reach of children, uses, warnings, ask a doctor before use, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
Antimicrobial
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.
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
For external use only.
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.
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
Aloe Barbadensis (Aloe) Leaf Juice, Aloe Barbadensis (Aloe) oil extract, Carbomer, Collagen, Elastin, Glycerin, Hyaluronic Acid, Triethanolamine, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben.
Product Label
Blaine Labs
RevitaDERM WOUND CARE GEL
3 fl. oz. PHYSICIAN FORMULA
NDC: 63347-120-01
(800) 307-8818 [email protected] www.BlaineLabs.com Blaine Labs, Inc. Santa Fe Springs, CA 90670 Rev. 20120820
Blaine Revitaderm1 (Blaine Revitaderm 1)
Blaine Revitaderm2 (Baline Revitaderm2)
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