Nizoral Psoriasis
Salicylic Acid
Kramer Laboratories
Human Otc Drug
NDC 55505-202Nizoral Psoriasis also known as Salicylic Acid is a human otc drug labeled by 'Kramer Laboratories'. National Drug Code (NDC) number for Nizoral Psoriasis is 55505-202. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Nizoral Psoriasis drug includes Salicylic Acid - 3 g/100mL . The currest status of Nizoral Psoriasis drug is Active.
Drug Information:
| Drug NDC: | 55505-202 |
| 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: | Nizoral Psoriasis |
| 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: | Salicylic Acid |
| 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: | Shampoo |
| 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: | SALICYLIC ACID - 3 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 Dec, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 03 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: | part358H |
| 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: | 205023
2467167
|
| 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: | O414PZ4LPZ
|
| 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 |
|---|
| 55505-202-64 | 1 BOTTLE in 1 CARTON (55505-202-64) / 325 mL in 1 BOTTLE | 01 Dec, 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 salicylic acid 3% psoriasis and seborrheic dermatitis
Product Elements:
Nizoral psoriasis salicylic acid salicylic acid salicylic acid water sodium c14-16 olefin sulfonate cocamidopropyl betaine peg-120 methyl glucose dioleate polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) trolamine panthenol .alpha.-tocopherol acetate tea tree oil green tea leaf ascorbic acid carton front label back label
Indications and Usage:
Uses relieves and helps prevent recurrence of scalp: irritation itching redness flaking scaling due to psoriasis and seborrheic dermatitis
Warnings:
Warnings for external use only
When Using:
When using this product avoid contact with eyes if contact occurs, rinse the eyes thoroughly with water
Dosage and Administration:
Directions for best results use at least twice a week or as directed by a doctor wet hair thoroughly massage liberal amount of product into scalp leave lather on for several minutes rinse thoroughly and repeat if needed
Package Label Principal Display Panel:
Principal display panel new nizoral ® psoriasis salicylic acid 3% shampoo & conditioner scalp psoriasis shampoo & conditioner with tea tree oil controls redness, flaking and scaling relieves itching and scalp irritation fast-acting starts working from first use sulfate, dye and alcohol-free 11 fl oz (325ml) specially formulated with: â tea tree oil â green tea â vitamin e â vitamin b5 â vitamin c free of: x sulfates x dyes x alcohol x artificial fragrances x preservatives x parabens what is scalp psoriasis? scalp psoriasis is a chronic inflammatory condition that comes and goes. symptoms may include irritation, itching, redness, and flaking. how does nizoral psoriasis shampoo & conditioner work? nizoral contains maximum strength medicine to relieve and help prevent scalp psoriasis symptoms while leaving hair clean and conditioned. the special formula contains tea tree oil, green tea and vitamins e, c and b5 - plus it's free of artificial fragrances, preservatives, and dyes that may irritate skin. read all information on this packaging and keep for future reference. before use, read all label information. if you have a drug reaction, contact a doctor and report it by calling: 1.800.824.4894 distributed by: kramer laboratories, inc. bridgewater, nj 08807 usa © 2020 kramer laboratories, inc. k0620 nizoral ® psoriasis salicylic acid 3% shampoo & conditioner scalp psoriasis shampoo & conditioner with tea tree oil controls redness, flaking and scaling relieves itching and scalp irritation fast-acting starts working from first use sulfate, dye and alcohol-free 11 fl oz (325ml)
Further Questions:
Questions or comments? call 800-824-4894