NDC 55505-194 Hc Max For Jock Itch


NDC Product Code 55505-194

NDC 55505-194-26

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC Product Information

Hc Max For Jock Itch with NDC 55505-194 is a a human over the counter drug product labeled by Kramer Laboratories. The generic name of Hc Max For Jock Itch is tolnaftate. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Kramer Laboratories

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.

Hc Max For Jock Itch 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: Kramer Laboratories
Labeler Code: 55505
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: 06-01-2020 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.

Hc Max For Jock Itch Product Label Images

Hc Max For Jock Itch 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 - Purpose

Active IngredientPurposeTolnaftate 1%Anti-fungal

Indications & Usage

Uses ■ Proven clinically effective in the treatment of most jock itch (tinea cruris). ■ For effective relief of itching, burning, or chafing associated with jock itch.


For external use only.

Otc - Do Not Use

Do not use on children under 2 years of age unless directed by a doctor.

Otc - When Using

When using this product ■ avoid contact with eyes.

Otc - Stop Use

Stop use and ask a doctor if ■ Irritation occurs. ■ There is no improvement within 2 weeks.

Otc - Keep Out Of Reach Of Children

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

Dosage & Administration

Directions ■ Clean the affected area with soap and warm water and dry thoroughly. ■ Apply a thin layer of HC Max™ Anti-Fungal Ointment over affected area twice daily (morning and night) or as directed by a doctor. ■ Supervise children in the use of this product. ■ For jock itch, use daily for 2 weeks. ■ If condition persists longer, consult a doctor. ■ This product is not effective on the scalp or nails.

Storage And Handling

Other information Store at controlled room temperature 15°-30°C (59°-86°F) Do not permit to freeze.

Inactive Ingredient

Inactive ingredientsAloe Vera Leaf, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Dimethicone 350, Eucalyptol, Glyceryl Monostearate,  Lavender Oil, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water (USP), Sodium Hydroxide,  Tea Tree Oil.

Otc - Questions

Questions? 1-800-824-4894

* Please review the disclaimer below.