Smooth Af
Tolnaftate
Pelli Skin Co.,llc.
Human Otc Drug
NDC 73046-124Smooth Af also known as Tolnaftate is a human otc drug labeled by 'Pelli Skin Co.,llc.'. National Drug Code (NDC) number for Smooth Af is 73046-124. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Smooth Af drug includes Tolnaftate - 1 g/100g . The currest status of Smooth Af drug is Active.
Drug Information:
| Drug NDC: | 73046-124 |
| 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: | Smooth Af |
| 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: | Pelli Skin Co.,llc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cloth |
| 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: | 11 Jul, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Jun, 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: | Pelli Skin Co.,LLC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2383335
|
| 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 |
|---|
| 73046-124-00 | 1 g in 1 PACKET (73046-124-00) | 11 Jul, 2019 | 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:
Purpose antifungal
Product Elements:
Smooth af tolnaftate caprylyl glycol sodium lauroyl sarcosinate water propanediol dioxolane disodium lauroamphodiacetate sodium laurate cottonseed oil tolnaftate tolnaftate peppermint oil .alpha.-tocopherol acetate ammonium acryloyldimethyltaurate/vp copolymer ethylhexyl stearate edetate disodium anhydrous eucalyptus oil dilauryl citrate phenoxyethanol cloth
Indications and Usage:
Uses ⢠proven clinically effective in the treatment of most athlete's foot 9tinea pedis) and ringworm (tinea corporis) ⢠helps prevent most athlete's foot with daily use ⢠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 when using this product avoid contact with the eyes. ⢠use only as directed; intentional misuse by deliberately concentrating and inhaling may harmful or fatal
Dosage and Administration:
Directions ⢠wash affected area with soap and water and dry thoroughly ⢠unfold and use towel to thoroughly clean and massage solution into entire foot soles, around and between toes ⢠sue new towel daily for 4 weeks; if condition persists longer, ask a doctor ⢠dispose of uses towel in bin, do not flush ⢠to prevent athlete's foot, use towel as directed once or twice daily (morning and/or night) ⢠for athlete's foot, wear well fitting, ventilated shoes and change shoes and socks at least once daily ⢠this product is not effective on the scalp or nails
Stop Use:
Stop use and ask a doctor ⢠if irritation occurs ⢠there is no improvement within 4 weeks
Package Label Principal Display Panel:
Label smooth af tm relief reinvented alcohol-free athlete's foot cure and prevention 1 treatment towel getsmoothaf.com a spa day in a towel approved american podiatric medical association pelli distributed by: pelli skin co., llc. mission, texas getsmoothaf.com 1 treatment towel: 7.0in x 8.0in (17.8cm x 20.32cm) a spa day in a towel all-in-one convenience fights odor & smells fresh safe for daily use scientific breakthrough focused on health alcohol & paraben free proactive formula non-greasy & absorbs quickly proactive layer advanced anti-fungal medication total foot care cleans & conditions revitalizes treats athlete's foot prevents athlete's foot the clean cure doctor recommended anti-fungal medicated foot towels. alcohol and paraben free. cures and prevents athlete's foot. safe and effective. great for athlete's foot diabetics foot odor patent pending proudly made in the usa rainforest alliance certified mix paper fsc fscr c109834 podiatrist recommended 14 individually wrapped treatment towels 7.0in x 8.0in (17.8cm x 20.32cm) label label
Further Questions:
Questions info@pelliskin.com