Opti-nail 2-in-1
Tolnaftate
Kramer Laboratories
Human Otc Drug
NDC 55505-219Opti-nail 2-in-1 also known as Tolnaftate is a human otc drug labeled by 'Kramer Laboratories'. National Drug Code (NDC) number for Opti-nail 2-in-1 is 55505-219. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Opti-nail 2-in-1 drug includes Tolnaftate - 1 g/100mL . The currest status of Opti-nail 2-in-1 drug is Active.
Drug Information:
| Drug NDC: | 55505-219 |
| 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: | Opti-nail 2-in-1 |
| 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: | 20 Jan, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 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: | Kramer Laboratories
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313423
2627287
|
| 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 |
|---|
| 55505-219-67 | 5 mL in 1 TUBE, WITH APPLICATOR (55505-219-67) | 20 Jan, 2023 | 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:
Product Elements:
Opti-nail 2-in-1 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 label directions
Indications and Usage:
Uses proven effective in the treatment of most athleteâs foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athleteâs 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 avoid contact with eyes.
Dosage and Administration:
Directions: clean affected area with soap and warm water and dry thoroughly. apply a thin layer of maximum strength antifungal over affected area twice daily (morning and night) or as directed by a doctor. the brush applicator allows for easy application to skin around the nail. wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. for athleteâs foot pay special attention to spaces between the toes. for athleteâs foot and ringworm, use daily for 4 weeks. for toe fungus, apply to skin around nails. if condition persists longer, consult a doctor. this product is not effective on the scalp or nails. supervise children in the use of this product.
Stop Use:
Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks.
Package Label Principal Display Panel:
Package label the only product that 1. improves nail appearance and 2. kills fungus around the nail new opti-nail⢠2-in-1 fungal nail repair + anti-fungal 1 improves nail appearance fungal nail repair formula apply directly on nail visible results starting in just 2 days net wt 5ml (.169 fl oz) 2 kills fungus around nail maximum strength antifungal (1% tolnaftate) apply to skin around nail clinically proven to cure & prevent fungal infections* net wt 5ml (.169 fl oz) includes: 1% tolnaftate antifungal solution and fungal nail repair formula *restores skin health + cures most athlete's foot step 1 apply fungal nail repair formula directly on nail clinically proven formula that results in healthier looking nails â visible results starting in just 2 days â triple action formula lightens, smooths, and moisturizes â easy to apply & dries quickly apply twice a day for 4 weeks, then use once daily as needed. fungal nail repair formula ingredients: ethyl lactate, glycerin, water, lactic acid, resacetophenone, citric acid (if needed for ph balance). for external use only. apply only to nail surface. avoid contact with eyes and mucus membranes. do not use if you are allergic to any of the ingredients in this product. keep out of reach of children. diabetics should ask a doctor before use. sunburn alert: may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. see package insert for full opti-nail 2-1 product instructions do not use if neck band is missing or broken k0322 fungal nail repair formula does not treat, cure, or prevent fungal infections. © 2022 kramer laboratories, inc. bridgewater, nj 08807 questions or comments? call 1-800-824-4894 patent pending step 2 apply maximum strength antifungal on skin around nail clinically proven to cure & prevent fungal infections â kills fungus â stops itching and burning â restores skin health + cures most athletes foot maximum strength anti-fungal not for nail or scalp fungus. cures most athlete's foot. opti-nail⢠2-in-1 fungal nail repair + antifungal directions for use always apply step 1 before step 2 first clean affected areas with soap and water and dry thoroughly step 1 apply fungal nail repair formula (green side) to nail surface unscrew the green cap. using the applicator, apply a thin layer of solution directly on entire affected nail surface twice daily (morning and evening). (solution looks clear.) nail surface will appear wet after application. avoid applying to skin around the nail. after applying, recap tightly and allow treated nails(s) to dry for a few minutes before beginning step 2. apply twice a day for 4 weeks, then use once daily as needed to maintain look. for external use only. avoid contact with skin. apply only to nail surface. avoid contact with eyes and mucous membranes. in case of contact with eyes, rinse cautiously with water for several minutes. may cause irritation if applied to skin. discontinue use in the event of an allergic reaction or irritation. do not use if you are allergic to any of the ingredients in the product. keep out of reach of children. avoid inhalation. diabetics should ask doctor before use. sunburn alert: this product contains alpha hydroxy acid (aha) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. use sunscreen, wear protective clothing, and limit sun exposure while using this product for a week afterwards. product is flammable, do not use near an open flame. fungal nail repair formula ingredients: ethyl lactate, glycerin, water, lactic acid, resacetophenone, citric acid (if needed for ph balance). fungal nail repair formula does not treat, cure, or prevent fungal infections step 2 apply maximum strength antifungal (blue side) to skin around nail unscrew the blue cap. using the applicator, apply a thin layer of medicine to skin around nails twice daily (morning and evening). (medicine looks white to off-white.) after applying, recap tightly and allow treated area to dry for a few minutes before putting on socks and shoes. apply twice a day for 4 weeks. for external use only. do not use on children under 2 years of age unless directed by a doctor. when using this product avoid contact with eyes. stop use and ask a doctor if irritation occurs of it there is no improvement within 4 weeks. keep out of reach of children. in case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice. maximum strength antifungal: active ingredient: tolnaftate 1% inactive ingredients: aloe vera (aloe barbadensis) gel, ascorbic acid (vitamin c), dimethicone, dmdm hydantoin, edetate disodium dihydrate, eucalyptol, glycerin, glyceryl stearate se, lavender oil, mineral oil, olive oil, peg-100 stearate, phenoxetol, propylene glycol, tea tree oil, titanium dioxide, tocopheryl acetate (vitamin e), xanthan gum, water maximum strength antifungal is not effective for nail or scalp fungus. cures most athlete's foot. ©2022 kramer laboratories, inc. bridgewater, nj 08807 questions or comments? call 1-800-824-4894 patent pending store at room temperature 15°â30°c (59°â86°f) k0322