NDC 70856-3581 Defense Antifungal Medicated Bar

Tolnaftate

NDC Product Code 70856-3581

NDC Code: 70856-3581

Proprietary Name: Defense Antifungal Medicated Bar Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Tolnaftate Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 70856 - Defense Soap Llc
    • 70856-3581 - Defense Antifungal Medicated Bar

NDC 70856-3581-2

Package Description: 1 NOT APPLICABLE in 1 CARTON > 119 g in 1 NOT APPLICABLE

NDC Product Information

Defense Antifungal Medicated Bar with NDC 70856-3581 is a a human over the counter drug product labeled by Defense Soap Llc. The generic name of Defense Antifungal Medicated Bar is tolnaftate. The product's dosage form is soap and is administered via topical form.

Labeler Name: Defense Soap Llc

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Defense Antifungal Medicated Bar Active Ingredient(s)

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

  • TOLNAFTATE 1 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM PALMATE (UNII: S0A6004K3Z)
  • SODIUM GLUCONATE (UNII: R6Q3791S76)
  • SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • PALM ACID (UNII: B6G0Y5Z616)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PALM KERNEL ACID (UNII: 79P21R4317)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Defense Soap Llc
Labeler Code: 70856
FDA Application Number: part333C Additional informationCallout TooltipWhat 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat 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: 02-01-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Defense Antifungal Medicated Bar Product Label Images

Defense Antifungal Medicated Bar 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 Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • Proven clinically effective in the treatment of most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris).For effective relief of itching, burning and cracking skin.

Warnings

For external use only

When Using This Product

When using this product avoid contact with the eye

Stop Use And Ask A Doctor If

Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

Do Not Use

Do Not use on children under 2 under of age except under the advice and supervision of a doctor.

Keep Out Of Reach Of Children.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wash affected area well and let product sit 1-2 minutes before rinsing.Make sure to dry affected area thoroughly.Supervise children in the use of this product.For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.This product is not effective on the scalp or nails.

Inactive Ingredients

Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Gluconate, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Palm Acid, Sodium Chloride, Palm Kernel Acid, Charcoal Powder

* Please review the disclaimer below.

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