Dermawound Wound Care Venous Stasis Ointment
FDA Label NDC 57554-120

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Progressive Doctors, Llc for the product Dermawound Wound Care Venous Stasis (NDC 57554-120). 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 ingredient, purpose, uses, warnings, do not use, ask a doctor before use, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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