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Mend19 Wound Care

Medically reviewed on March 21, 2018

Dosage form: ointment
Ingredients: POVIDONE-IODINE 10g in 100g
Labeler: Wound Care USA, LLC
NDC Code: 57554-210

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

MEND19™ Wound Care Iodine Topical Ointment

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 MEND19™, evaluate the wound or ulcer to insure no excessive bleeding is present. Never wipe out the ulcer.
  • Apply a moderate amount of MEND19™ directly to affected area.
  • Deeper or "tunneling" wounds may require packing and/or sides coated with additional MEND19™ 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 MEND19™ 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.MEND19.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# 57554-210-06

Package/Label Principal Display Panel

MEND19™ Wound Care Iodine Topical Ointment

Original Formula

Net Wt. 6 oz. (179 g)

Carton Label

MEND19 WOUND CARE 
povidone-iodine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57554-210
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE 
CALCIUM CARBONATE 
GLYCERIN 
XANTHAN GUM 
METHYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:57554-210-061 TUBE in 1 CARTON
1179 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/08/2013
Labeler - Wound Care USA, LLC (006745854)

 
Wound Care USA, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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