Fungi Nail Anti-fungal Pen
Tolnaftate
Kramer Laboratories
Human Otc Drug
NDC 55505-193Fungi Nail Anti-fungal Pen also known as Tolnaftate is a human otc drug labeled by 'Kramer Laboratories'. National Drug Code (NDC) number for Fungi Nail Anti-fungal Pen is 55505-193. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Fungi Nail Anti-fungal Pen drug includes Tolnaftate - 1 g/100mL . The currest status of Fungi Nail Anti-fungal Pen drug is Active.
Drug Information:
| Drug NDC: | 55505-193 |
| 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: | Fungi Nail Anti-fungal Pen |
| 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: | Liquid |
| 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/100mL
|
| 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: | 01 Mar, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | 313423
|
| 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 |
|---|
| 55505-193-51 | 1 TUBE, WITH APPLICATOR in 1 CARTON (55505-193-51) / 3 mL in 1 TUBE, WITH APPLICATOR | 01 Mar, 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 purpos e tolnaftate 1% anti-fungal
Product Elements:
Fungi nail anti-fungal pen tolnaftate tolnaftate tolnaftate aloe vera leaf ascorbic acid dimethicone dmdm hydantoin edetate disodium eucalyptol glycerin glyceryl stearate se lavender oil mineral oil olive oil peg-100 stearate phenoxyethanol propylene glycol tea tree oil titanium dioxide .alpha.-tocopherol acetate xanthan gum water carton front carton back
Indications and Usage:
Uses â proven effective in the treatment of most athlete's 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 water and dry thoroughly. â apply a thin layer of fungi-nail ® anti-fungal 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 athlete's foot pay special attention to spaces between the toes. â for athlete's foot and ringworm, use daily for 4 weeks. â to prevent athlete's foot, apply once or twice daily (morning and/or night). â for toe fungus, apply under nail and cuticle area. if condition persists longer, consult a doctor. â the 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 medicine maximum strength fungi-nail ® anti-fungal pen clinically proven to cure and prevent fungal infections maximum strength fungi-nail ® plus aloe & tea tree oil triple action formula â kills fungus â stops itching & burning â restores skin health + cures most athlete's foot clincally proven ingredient .101 fl oz (3ml) fungi-nail ® maximum strength anti-fungal plus 5 natural oils: â aloe vera â lavender â tea tree â olive oil â eucalyptol and antioxidants vitamin e and vitamin c fungi-nail ® is specially formulated to kill fungus and restore skin health deep penetrating medicine that stays in place convenient and easy to apply pen applicator instructions for use: twist base with brush pointing upward to saturate brush. i f you do not hear a click, turn the other way. first time use may require up to 40 twists to initiate product flow. for best results treat around all toenails and in between toes. not for nail or scalp fungus. cures most athlete's foot. k1220 do not use if neckband is broken or missing for more information about fungi-nail l® and money back guarantee, visit us at funginail.com kramer laboratories kramer laboratories, inc. bridgewater, nj 08807 1-800-824-4894