Bodewell Psoriasis Scalp Relief Treatment
Salicylic Acid
The Procter & Gamble Manufacturing Company
Human Otc Drug
NDC 69423-617Bodewell Psoriasis Scalp Relief Treatment also known as Salicylic Acid is a human otc drug labeled by 'The Procter & Gamble Manufacturing Company'. National Drug Code (NDC) number for Bodewell Psoriasis Scalp Relief Treatment is 69423-617. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Bodewell Psoriasis Scalp Relief Treatment drug includes Salicylic Acid - 1.95 g/100mL . The currest status of Bodewell Psoriasis Scalp Relief Treatment drug is Active.
Drug Information:
| Drug NDC: | 69423-617 |
| 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: | Bodewell Psoriasis Scalp Relief Treatment |
| 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: | The Procter & Gamble Manufacturing Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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 - 1.95 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: | 15 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | The Procter & Gamble Manufacturing Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2594494
|
| 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 |
|---|
| 69423-617-11 | 118 mL in 1 BOTTLE, SPRAY (69423-617-11) | 15 Feb, 2022 | 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 psoriasis
Product Elements:
Bodewell psoriasis scalp relief treatment salicylic acid smilax aristolochiifolia root sodium citrate, unspecified form sanguinaria canadensis root sambucus nigra whole scrophularia nodosa populus alba bark populus tremuloides bark glycereth-25 pca isostearate hamamelis virginiana top achillea millefolium whole water alcohol althaea officinalis root berberis vulgaris root bark caprylyl glycol matricaria recutita flowering top glycerin salicylic acid salicylic acid tussilago farfara leaf vincetoxicum hirundinaria root phenoxyethanol lens culinaris fruit phytolacca americana root veronica officinalis whole malva sylvestris leaf nasturtium officinale leaf pimpinella saxifraga whole horse chestnut xanthan gum 1,2-hexanediol cochlearia officinalis flowering top hydroxyethyl cellulose, unspecified polidocanol sodium hydroxide
Indications and Usage:
Uses helps eliminate skin itching, redness, irritation, ï¬aking and scaling associated with psoriasis. helps prevent recurrence of the symptoms of psoriasis.
Warnings:
Warnings for external use only. when using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water. stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. for prolonged periods without consulting a doctor. if condition covers a large area of the body, consult your doctor before using this product. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately.
Do Not Use:
Warnings for external use only. when using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water. stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. for prolonged periods without consulting a doctor. if condition covers a large area of the body, consult your doctor before using this product. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately.
When Using:
When using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water.
Dosage and Administration:
Directions apply to affected areas one to four times daily or as directed by a doctor.
Stop Use:
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.
Package Label Principal Display Panel:
Principal display panel - 118 ml bottle bodewell psoriasis scalp relief treatment salicylic acid psoriasis serum 4.0 fl oz (118 ml) bodewell
Further Questions:
Questions (or comments)? 1-800-213-1873