Hc Max For Athletes Foot
Tolnaftate
Kramer Laboratories
Human Otc Drug
NDC 55505-203Hc Max For Athletes Foot also known as Tolnaftate is a human otc drug labeled by 'Kramer Laboratories'. National Drug Code (NDC) number for Hc Max For Athletes Foot is 55505-203. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Hc Max For Athletes Foot drug includes Tolnaftate - 1 g/100g . The currest status of Hc Max For Athletes Foot drug is Active.
Drug Information:
| Drug NDC: | 55505-203 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Hc Max For Athletes Foot |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Tolnaftate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Kramer Laboratories |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | TOLNAFTATE - 1 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 13 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333C |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Kramer Laboratories
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 199126
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 06KB629TKV
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 55505-203-26 | 1 TUBE in 1 CARTON (55505-203-26) / 28 g in 1 TUBE | 13 May, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Active ingredient purpose tolnaftate 1% anti-fungal
Product Elements:
Hc max for athletes foot tolnaftate tolnaftate tolnaftate water carbomer homopolymer type a (allyl pentaerythritol crosslinked) phenoxyethanol dimethicone 350 glyceryl monostearate poloxamer 188 aloe vera leaf eucalyptol lavender oil olive oil tea tree oil sodium hydroxide carton tube
Indications and Usage:
Uses â proven effective in the treatment of most athleteâs foot (tinea pedis) and ringworm (tinea corporis). â helps prevent most athlete's foot with daily use. â for effective relief of itching, burning and cracking.
Warnings:
Warnings for external use only.
Do Not Use:
Warnings for external use only.
When Using:
When using this product â avoid contact with eyes.
Dosage and Administration:
Directions â clean affected area with soap and warm water and dry thoroughly. â apply a thin layer of hc max⢠anti-fungal ointment over affected area twice daily (morning and night) or as directed by a doctor. â wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. â for athleteâs foot pay special attention to spaces between the toes. â for athleteâs foot and ringworm, use daily for 4 weeks. â to prevent athlete's foot, clean the feet and dry thoroughly. apply a thin layer of the product to the feet once or twice daily (morning and/or night). if condition persists longer, consult a doctor. â this product is not effective on the scalp or nails. â supervise children in the use of this product.
Stop Use:
Stop use and ask a doctor if â irritation occurs. â there is no improvement within 4 weeks.
Package Label Principal Display Panel:
Principal display panel maximum strength / máxima potencia hc max⢠anti-fungal ointment / ungüento anti-hongos for athlete's foot cures and prevents most athlete's foot relives: â itching â burning â cracking cura y previene la mayorÃa de casos de pie de atleta alivia: â picazón â ardor â agrietamiento maximum strength / máxima potencia hc max⢠tolnaftate 1% plus aloe & tea tree oil for skin health clinically proven ingredient for athlete's foot net wt 1 oz (28gm) kramer laboratories distributed by: kramer laboratories inc. bridgewater, nj 08807 1-800-824-4894 k1219 kramer laboratories kramer laboratories, inc. bridgewater, nj 08807 1-800-824-4894 k1219 maximum strength / máxima potencia hc max⢠for athlete's foot anti-fungal ointment / ungüento anti-hongos tolnaftate 1% net content 1 oz. (28g)