Jack Black Clearing Spot Treatment
Sulfur
Jack Black Llc
Human Otc Drug
NDC 66738-436Jack Black Clearing Spot Treatment also known as Sulfur is a human otc drug labeled by 'Jack Black Llc'. National Drug Code (NDC) number for Jack Black Clearing Spot Treatment is 66738-436. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Jack Black Clearing Spot Treatment drug includes Sulfur - .5 g/100g . The currest status of Jack Black Clearing Spot Treatment drug is Active.
Drug Information:
| Drug NDC: | 66738-436 |
| 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: | Jack Black Clearing Spot 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: | Sulfur |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Jack Black Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | SULFUR - .5 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: | 12 Feb, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 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: | M006 |
| 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: | Jack Black LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 70FD1KFU70
|
| 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 |
|---|
| 66738-436-01 | 1 TUBE in 1 CARTON (66738-436-01) / 15 g in 1 TUBE | 12 Feb, 2021 | 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 acne treatment
Product Elements:
Jack black clearing spot treatment sulfur water butylene glycol glycerin propanediol ethylhexylglycerin curcuma longa whole camellia sinensis flower aloe medium-chain triglycerides acacia senegal flower magnesium aluminum silicate glyceryl monostearate peg-100 stearate pentylene glycol alkyl (c12-15) benzoate phenoxyethanol decylene glycol zinc pidolate sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 mw) xanthan gum sodium pyrrolidone carboxylate isohexadecane ganoderma lucidum whole sodium hydroxide levomenol polysorbate 80 lysine tetrasodium glutamate diacetate 10-hydroxydecanoic acid sebacic acid magnesium chloride potassium chloride sodium chloride 1,10-decanediol zinc chloride sulfur sulfur
Indications and Usage:
Uses for the treatment of acne dries and clears acne blemishes and blackheads and allows skin to heal.
Warnings:
Warnings for external use only when using this product apply only to areas with acne skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical medication at a time. avoid product contact with silver jewelry. keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away do not use on broken skin on large areas of the skin
Do Not Use:
Warnings for external use only when using this product apply only to areas with acne skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical medication at a time. avoid product contact with silver jewelry. keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away do not use on broken skin on large areas of the skin
When Using:
When using this product apply only to areas with acne skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical medication at a time. avoid product contact with silver jewelry. keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away
Dosage and Administration:
Directions clean the skin thoroughtly before applying this product cover the entire ara with a thin layer one to three times daily because excess drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
Package Label Principal Display Panel:
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