NDC 55505-195 Hc Max Anti-fungal

Tolnaftate

NDC Product Code 55505-195

NDC 55505-195-62

Package Description: 150 g in 1 CAN

NDC Product Information

Hc Max Anti-fungal with NDC 55505-195 is a a human over the counter drug product labeled by Kramer Laboratories. The generic name of Hc Max Anti-fungal is tolnaftate. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Kramer Laboratories

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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 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 1.5 g/150g

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.

  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • ISOBUTANE (UNII: BXR49TP611)
  • PPG-12-BUTETH-16 (UNII: 58CG7042J1)
  • ALCOHOL (UNII: 3K9958V90M)

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: 05-28-2020 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 Anti-fungal Product Label Images

Hc Max 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 - Purpose

Active ingredientPurposeTolnaftate 1%Anti-fungal

Indications & Usage

Uses ■ proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ prevents the recurrence of most athlete's foot with daily use ■ for effective relief of itching, cracking and burning

Warnings

For external use only.

Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Otc - When Using

When using this product ■ avoid contact with eyes or mouth ■ use only as directed

Otc - Stop Use

Stop use and ask a doctor if ■ Irritation occurs ■ no improvement within 4 weeks

Otc - Do Not Use

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

Otc - 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.

Dosage & Administration

Directions ■ wash affected area and dry thoroughly ■ shake can well and spray a thin layer over affected area twice daily (morning and night) ■ supervise children in the use of this product ■ for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily ■ use daily for 4 weeks ■ if condition persists, consult a doctor ■ to prevent athlete's foot, apply once or twice daily (morning and/or night) ■ This product is not effective on the scalp or nails.

Storage And Handling

Other information store between 20º and 30º C (68º-86ºF)

Inactive Ingredient

Inactive ingredients  BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B (36% w/w)

* Please review the disclaimer below.