Grandpas Thylox Acne Treatment With Sulfur
Sulfur
Bradford Soap Works, Inc.
Human Otc Drug
NDC 11118-1006Grandpas Thylox Acne Treatment With Sulfur also known as Sulfur is a human otc drug labeled by 'Bradford Soap Works, Inc.'. National Drug Code (NDC) number for Grandpas Thylox Acne Treatment With Sulfur is 11118-1006. This drug is available in dosage form of Soap. The names of the active, medicinal ingredients in Grandpas Thylox Acne Treatment With Sulfur drug includes Sulfur - 3 g/100g . The currest status of Grandpas Thylox Acne Treatment With Sulfur drug is Active.
Drug Information:
| Drug NDC: | 11118-1006 |
| 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: | Grandpas Thylox Acne Treatment With Sulfur |
| 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: | Bradford Soap Works, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Soap |
| 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 - 3 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: | 20 Feb, 2007 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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: | part333D |
| 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: | Bradford Soap Works, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 248410
1793760
|
| 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: | 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 |
|---|
| 11118-1006-6 | 92 g in 1 BOX (11118-1006-6) | 20 Feb, 2007 | 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 soap
Product Elements:
Grandpas thylox acne treatment with sulfur sulfur sulfur sulfur palm oil coconut oil water glycerin titanium dioxide etidronate tetrasodium pentasodium pentetate
Indications and Usage:
Uses acts four ways to improve blemished skin: softens the hard shell of acne blemishes (keratolytic action). helps dissolve and remove blackheads. washes away excess oils which may cause blackheads. freshens skin by its thorough cleansing action. warings for external use only. using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. if this occurs, only one medication should be used unless directed by a doctor. do not get into eyes. stop use and ask a doctor if excessive skin irritation develpoes or increases.
Warnings:
Warings for external use only. using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. if this occurs, only one medication should be used unless directed by a doctor. do not get into eyes.
Dosage and Administration:
Directions use twice daily. work up a lather with hands or washcloth and apply to affected areas without scrubbing. let dry about one minute, rinse thoroughly, and pat dry.
Stop Use:
Stop use and ask a doctor if excessive skin irritation develpoes or increases.
Package Label Principal Display Panel:
Thylox® all natural, 100% vegetable base acne treatment with 3% sulfur drug facts active ingredient purpose sulfur 3%. .. acne treatment soap uses § for the treatment of acne. warnings for external use only. using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation to the skin. if this occurs, only on medication should be used unless directed by a doctor. when using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. stop use and ask a doctor if excessive skin irritation develops or increases. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately. directions work up a lather and gently massage into affected areas. leave on for one minute, rinse thoroughly, and pat dry. use morning and night for best results. inactive ingredients sodium palmate®, sodium cocoate/sodium palm kernelate, water (aqua), glycerin, jasminum officinale (jasmine) oil, cananga odorata leaf oil, glyine soja (soybean) oil, sodium chloride, sodium gluconate an age-old treatment for troubled skin ideal for skin prone to acne and inflammation, this treatment soap harnesses the healing properties of natural sulfur to prevent and eliminate breakouts, blackheads and excess oil. also phthalates, sulfates, parabene, edta, gluten, animal by-products, artificial fragrances or colorants the grandpa soap company the grandpa soap co. thylox® acne treatment from our family to yours since 1878 3% sulfur hardworking, simple, pure ingredients are the heart of our naturalsoapmaking tradition from our family to yours net wt 3.25 oz (926) face & body bar soap thylox soap