Caribbean Beauty - Scalp Treatment Mask
Salicylic Acid
Zm Group Of Companies
Human Otc Drug
NDC 82937-003Caribbean Beauty - Scalp Treatment Mask also known as Salicylic Acid is a human otc drug labeled by 'Zm Group Of Companies'. National Drug Code (NDC) number for Caribbean Beauty - Scalp Treatment Mask is 82937-003. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Caribbean Beauty - Scalp Treatment Mask drug includes Salicylic Acid - 7.0753 g/237mL . The currest status of Caribbean Beauty - Scalp Treatment Mask drug is Active.
Drug Information:
| Drug NDC: | 82937-003 |
| 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: | Caribbean Beauty - Scalp Treatment Mask |
| 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: | Zm Group Of Companies |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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 - 7.0753 g/237mL
|
| 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: | 29 Aug, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 04 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: | M032 |
| 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: | ZM Group of companies
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 205023
|
| 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: | 0783495676157
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 82937-003-08 | 237 mL in 1 BOTTLE (82937-003-08) | 29 Aug, 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:
Anti-dandruff anti-psoriasis anti-seborrheic dermatitis
Product Elements:
Caribbean beauty - scalp treatment mask salicylic acid glycol stearate sodium lauryl sulfate almond oil threonine phenylalanine histidine sodium pyrrolidone carboxylate water dimethicone 350 phenoxyethanol methylpropanediol sodium hydroxide tea tree oil salicylic acid salicylic acid biotin pyridoxine hydrochloride alpha-tocopherol acetate sodium lactate pyrrolidone carboxylic acid propylene glycol glyceryl stearate/peg-100 stearate glycerin caprylhydroxamic acid caprylyl glycol arginine isoleucine limonene, (+)- isopropyl myristate stearyl alcohol aloe vera leaf valine corn oil aspartic acid glycine alanine serine hamamelis virginiana leaf peppermint oil menthol peg-25 hydrogenated castor oil vitamin a palmitate sodium ascorbyl phosphate proline
Indications and Usage:
Use reduces and helps eliminate recurrence of flaking and itching associated with dandruff, psoriasis and seborrheic dermatitis.
Warnings:
For external use only.
When Using:
Avoid contact with the eyes. if contact occurs, rinse eyes thoroughly with water.
Dosage and Administration:
Dampen hair and apply the scalp treatment mask directly to the scalp in inch partings, gently massage over entire scalp and cover with a shower cap for 20-30 minutes. remove cap and gently massage scalp for about 5-7 minutes. rinse, shampoo, condition and style as usual. for best results use at least twice a week or as directed by a doctor.
Stop Use:
Stop use and ask doctor if condition worsens or does not improve after regular use of this product as directed.
Package Label Principal Display Panel:
Caribbean beauty - scalp treatment mask scalp treatment