NDC 0295-4629 Hongo Cura Maximum Strength Anti-fungal

Tolnaftate 1%

NDC Product Code 0295-4629

NDC 0295-4629-06

Package Description: 28 g in 1 TUBE

NDC Product Information

Hongo Cura Maximum Strength Anti-fungal with NDC 0295-4629 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc. The generic name of Hongo Cura Maximum Strength Anti-fungal is tolnaftate 1%. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Denison Pharmaceuticals, 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.

Hongo Cura Maximum Strength Anti-fungal 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.

  • TOLNAFTATE 1 g/100g

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)

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.
  • 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: Denison Pharmaceuticals, Llc
Labeler Code: 0295
FDA Application Number: part333C 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 07-11-2019 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: 12-31-2020 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.

Hongo Cura Maximum Strength Anti-fungal Product Label Images

Hongo Cura Maximum Strength Anti-fungal 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

Otc - Active Ingredient

Active ingredient Tolnaftate 1%

Otc - Purpose


Indications & Usage

  • UsesProven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). Helps prevent most athlete's foot with daily use.For effective relief of itching, burning and cracking.


WarningsFor external use only.

Otc - Do Not Use

  • Do not use on children under 2 years of age unless directed by a doctor.
  • When using this productavoid contact with eyes.

Otc - Stop Use

  • Stop use and ask a doctor ifIrratation occurs.There is no improvement within 4 weeks.

Otc - Keep Out Of Reach Of Children

KEEP THIS AND ALL MEICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physican, emercy medical car facility or Poison Control Center immediately for advice.

Dosage & Administration

  • DirectionsClean affected area with soap and warm water and dry throrughyApply a thin layer of HC Max
  • TM Anti-fungal Ointment over affeted area twice daily (morning and night) or as directed by a doctor.
  • Wear well-fitting, ventilated shoes, and change shoes and socks at least once dialy.For athlete's foot pay special atnetion to spaces between the toes.For athlete's foot and ringworm, use daily for 4 weeks.For toes fungus, apply under nail and around cuticle area. If condition persists longer, consult a doctor.This product is not effective on the scalp or nails.Supervise children in the use of this product.

Other Safety Information

Other informationStore at controlled room temperature 15º-30º C (59º-86ºF) Do not permit to freeze.

Inactive Ingredient

Inactive IngredientsPurified Water USP, Carborner Homopolymer Type A (Alyl Pentaerythritol Crosslinked), Phenoxyethanol. Dimethicone 350, Glyceryl Monostearate, Poloxamer 188, Aloe Vera Leaf, Eucalyptol, Lavender Oil, Olive Oil, Tea Tree Oil, Sodium Hydroxide.

* Please review the disclaimer below.