FDA Label for Dermawound Wound Care
View Indications, Usage & Precautions
Dermawound Wound Care Product Label
The following document was submitted to the FDA by the labeler of this product Progressive Doctors, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Povidone-iodine 10% (0.65% available iodine)
Purpose
First aid antiseptic
Uses
first aid antiseptic to help prevent infection in minor
- cuts
- scrapes
- burns
Warnings
For external use only
Do Not Use
- in the eyes
- over large areas of the body
- if pregnant or lactating
Ask A Doctor Before Use
in case of deep or puncture wounds, animal bites, or serious burns.
Stop Use And Ask A Doctor If
- the condition persists or gets worse
- irritation or rash appears
- you need to use the product for more than 1 week
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Gently clean the affected area
- Prior to application of DermaWound®, evaluate the wound or ulcer to insure no excessive bleeding is present. Never wipe out the ulcer.
- Apply a moderate amount of DermaWound® directly to affected area.
- Deeper or "tunneling" wounds may require packing and/or sides coated with additional DermaWound® and sterile gauze.
- Apply additional sterile gauze to absorb exudates, if needed.
- Change Dressing 2 or 3 times daily or as directed by a physician.
- May require supervision of a health care professional in the management of chronic & acute wound care, pressure sores, diabetic ulcers, surgical wounds & indwelling catheters.
Cautions
- Persons allergic or sensitive to iodine should avoid contact with this product.
- Do not restrict circulation when applying DermaWound® with sterile gauze.
- Apply additional sterile gauze to absorb exudates, if needed.
- Change Dressing 2 or 3 times daily or as directed by a physician.
Other Information
- Store at 59°-86°F (15-30°C)
- Avoid Heat and Direct Sunlight
Inactive Ingredients
Sucrose (Poly-saccharide Blend), Calcium Carbonate (Poly-mineral Blend, vegan), Glycerin, Xantham gum, Methylparaben and Deionized Water.
Questions Or Comments?
www.ProgressiveDoctors.com or 1-866-727-0462
Non-irritating, Clinically tested, and Allergy tested.
Eco-Friendly / Certified Green Manufacturing Contents Biodegradable
Manufactured for and Distributed by Wound Care USA, LLC, Tucson, Arizona 85712
©2013 U.S. & International Patents Pending
Made in U.S.A.
Made With Solar Power
NDC# 57554-110-06
Package/Label Principal Display Panel
DermaWound® Professional Care
Wound Care Iodine Topical Ointment
Original Formula
Net Wt. 6 oz. (179 g)
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