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  5. Label Information: Dermawound Wound Care Venous Stasis

FDA Label for Dermawound Wound Care Venous Stasis

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. CAUTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Dermawound Wound Care Venous Stasis 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



Benzocaine Hydrochloride (1.27%)


Purpose



Local Anesthetic


Uses



topical pain relief of minor

  • •cuts
  • •scrapes
  • •burns

Warnings



For external use only


Do Not Use



  • •in the eyes
  • •if you have methemoglobinemia
  • •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 around 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 and/or benzocaine 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, Xanthan Gum, PVP-Iodine, Methylparaben, and Deionized Water.


Questions Or Comments?



www.DermaWound.com or 1-866-727-0462

Non-irritating, Clinically tested, and Allergy tested.

Certified Green Manufacturing
Contents Biodegradable
Eco-Friendly

Manufactured for and Distributed by Wound Care USA, LLC
Tucson, Arizona 85712

©2014 U.S. & International Patents Pending

Made With Solar Power

Made in U.S.A.
NDC# 57554-120-06

Stir if Separated


Package/Label Principal Display Panel



DermaWound® Professional Care

Wound Care Local Anesthetic Ointment

Venous Stasis Formula

Net Wt. 6 oz. (179 g)

Carton Label - image 01

Carton Label - image 01


Carton Label


* Please review the disclaimer below.