NDC 57554-130 Ez Woundcare Pain Relieving And First Aid Antiseptic

Benzocaine, Povidone-iodine

NDC Product Information

Ez Woundcare Pain Relieving And First Aid Antiseptic with NDC 57554-130 is a a human over the counter drug product labeled by Ez Medical Solutions Llc. The generic name of Ez Woundcare Pain Relieving And First Aid Antiseptic is benzocaine, povidone-iodine. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Ez Medical Solutions Llc

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ez Woundcare Pain Relieving And First Aid Antiseptic Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZOCAINE 50 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • SUCROSE (UNII: C151H8M554)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ez Medical Solutions Llc
Labeler Code: 57554
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Ez Woundcare Pain Relieving And First Aid Antiseptic Product Label Images

Ez Woundcare Pain Relieving And First Aid Antiseptic Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Banzocaine 5.0%Povidone Iodine 7.0%


Pain RelievingFirst Aid Antiseptic


  • First aid to help prevent infection in minor cuts, scrapes, and burns.For the temporary relief of pain in minor cuts, scrapes, and burns.


For external use only.

Do Not Use

In the eyes.

When Using This Product:

  • Avoid contact with the eyes.do not apply to large areas of the body.in case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop Use And Ask A Doctor If

Condition worsens, or if symptoms persist for more than 7 days or clean up and occur again within a few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


  • Clean the affected area. Adults and children 2 years of age and older: Apply a small amount of this product on the affected area 1 to 3 times dailyMay be covered by a sterile bandage.Children under 2 years of age: Consult a doctor.

Other Information

  • Store at 59-86°F (15-30°C)Avoid heat and direct sunlight.

Inactive Ingredients

Calcium carbonate, deionized water, glycerin, sucrose, methylparaben, xanthan gum

* Please review the disclaimer below.