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Product NDC Code | 57554-110 | ||||
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Drug Name | Dermawound wound care |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | OINTMENT | ||||
RxCUI drug identifier | 312563, 1432885 |
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Application Number | M003 | ||||
Labeler Name | Progressive Doctors, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Povidone-iodine 10% (0.65% available iodine)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Sucrose (Poly-saccharide Blend), Calcium Carbonate (Poly-mineral Blend, vegan), Glycerin, Xantham gum, Methylparaben and Deionized Water.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses first aid antiseptic to help prevent infection in minor cuts scrapes burns
Purpose
Information about the drug product’s indications for use.Purpose First aid antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.DermaWound Wound Care povidone-iodine SUCROSE CALCIUM CARBONATE GLYCERIN XANTHAN GUM METHYLPARABEN WATER POVIDONE-IODINE IODINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package/Label Principal Display Panel DermaWound Professional Care ® Wound Care Iodine Topical Ointment Original Formula Net Wt. 6 oz. (179 g) DermaWound Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use in the eyes over large areas of the body if pregnant or lactating
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.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
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API