Homehealth Antifungal
Tolnaftate
Home Health
Human Otc Drug
NDC 76020-100Homehealth Antifungal also known as Tolnaftate is a human otc drug labeled by 'Home Health'. National Drug Code (NDC) number for Homehealth Antifungal is 76020-100. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Homehealth Antifungal drug includes Tolnaftate - 10 mg/mL . The currest status of Homehealth Antifungal drug is Active.
Drug Information:
| Drug NDC: | 76020-100 |
| 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: | Homehealth Antifungal |
| 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: | Home Health |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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 - 10 mg/mL
|
| 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: | 14 Feb, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| 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, 2024 |
| 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: | Home Health
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 283693
|
| 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. |
| UPC: | 0318858118120
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 76020-100-04 | 118 mL in 1 BOTTLE (76020-100-04) | 14 Feb, 2011 | 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:
Uses - proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm with daily use. - helps prevent most athlete's foot with daily use. - for effective relief of itching, burning and cracking.
Product Elements:
Homehealth antifungal tolnaftate almond oil aloe vera leaf calendula officinalis flower castor oil cetyl alcohol grapefruit cocoa butter diazolidinyl urea lanolin lavender oil methylparaben propylene glycol propylparaben rosemary oil stearic acid tea tree oil thyme oil trolamine water tolnaftate tolnaftate
Indications and Usage:
When using this product avoid contact with eyes.
Warnings:
Warnings for external use only.
Do Not Use:
Warnings for external use only.
Dosage and Administration:
Directions - clean the affected area and dry thoroughly; - apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a physician; - 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. - for jock itch, use daily for 2 weeks. - for athlete's foot and ringworm, use daily for 4 weeks. - if condition persists longer, consult a doctor. - this product is not effective on the scalp or nails.
Stop Use:
Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch. stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm.
Description:
Antifungal lotion provides effective relief of itching, scaling, burning, irritation and discomfort associated with athlete's foot, jock itch and ringworm. the active ingredient, tolnaftate, combines with a soothing base of natural botanical extracts to yield a truly unique formula. you can count on home health to deliver the natural heath products your family deserves. no mineral oil, no petroleum, no artificial colors, no artificial fragrance. carefully manufactured for homehealth, co. ronkonxoma, ny 11779 u.s.a. 800-445-7137 www.homehealthus.com 2009 home health b11812 03b
Package Label Principal Display Panel:
Homehealth natural health begins at home antifungal lotion tolnaftate proven clinicallyl effective in the threatment of most athlete's foot, jock itch, ringworm net wt. 4 fl. oz. (118ml)
Antifungal lotion