Palmers Skin Success
Sulfur
Bradford Soap Works, Inc.
Human Otc Drug
NDC 11118-7386Palmers Skin Success also known as Sulfur is a human otc drug labeled by 'Bradford Soap Works, Inc.'. National Drug Code (NDC) number for Palmers Skin Success is 11118-7386. This drug is available in dosage form of Soap. The names of the active, medicinal ingredients in Palmers Skin Success drug includes Sulfur - 3 g/100g . The currest status of Palmers Skin Success drug is Active.
Drug Information:
| Drug NDC: | 11118-7386 |
| 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: | Palmers Skin Success |
| 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: | 15 Jun, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Jun, 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
|
| 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 |
|---|
| 11118-7386-1 | 100 g in 1 BOX (11118-7386-1) | 15 Jun, 2016 | N/A | No |
| 11118-7386-2 | 140 g in 1 BOX (11118-7386-2) | 15 Jun, 2016 | 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:
Palmers skin success sulfur sulfur sulfur sodium palmate sodium cocoate water glycerin .alpha.-tocopherol acetate sodium chloride titanium dioxide etidronate tetrasodium pentasodium pentetate disodium distyrylbiphenyl disulfonate
Indications and Usage:
Uses deep cleansing antibacterial soap for the relief and control of acne, blackheads and pimples
Warnings:
Warnings for external use only
When Using:
When using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water. skin irritation is more likely to occur if you use another topical acne medication at the same time if irritation occurs, use only one topical acne medication at a time
Dosage and Administration:
Directions work into a lather and rinse with warm water
Stop Use:
Stop use and ask a doctor if irritation occurs or worsens
Package Label Principal Display Panel:
Palmer's skin success product label palmerâs® skin success® the experts in even skin tone since 1840 medicated complexion bar 310821 made with natural vitamin e (tecopheral) drug facts (continued) inactive ingredients: sodium palmate, sodium cocoate (or) sodium palm kernelate, watr (aqua), glycerin, tocopheryl, sodium chloride, titanium dioxide (ct77891), tetrasodium etidronate, pentasodium pentetate, disodium distyrylbiphenyl disulfonate, frangrance, (parfum) benzyl alcohol, benzyl benzoate, linalol questions or comments? 1-800-378-6123 in the us palmerâs® skin success® anti acne medicated complexion bar purifica suavemente y desintoxica la superficie que pueden obstruir los poros y causar brotes de acne. la piel se siente al instante removado y con el uso continuo es mas claro, mas luminosa y equilbrada instrucciones. utilice agua templada para crear una espuma generosa y masajee sobre la piel, enjuague por complete. advertencias: solo para uso externo. evite el contacto con los ojos. mantenga el product fuera del alcance de los ninos. advanced formula palmerâs® skin success® the experts in even skin tone since 1840 anti-acne medicated complexion bar drug facts active ingredient purpose sulfur 3% â¦â¦â¦acne treatment soap uses § deep cleansing antibacterial soap for relief and control of acne, blackheads and pimples warnings for external use only when using this product § apply only to areas with acne § avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water do not use on § broken skin § large areas of the skin keep out of reach of children . if swallowed, get medical help or contact a poison control center right away § skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, use only one topical acne medication at a time. stop use and ask a doctor if irritation occurs or worsens palmerâs® skin success® the experts in even skin tone since 1840 anti-acne palmerâs® sin success® anti-acne medicated complexion bar gently purifies & detoxifies skin of surface bacteria that can clog pores and lead to acne breakouts. skin feels instantly refreshed and with continued use is clearer, more luminous and balanced free of: § sulfates, parabens, phthalates, mineral oil, gluten, dyes perfect for: § oily, acne-prone skin key ingredient § 3% sulfur palmerâs® is against animal testing. palmerâs® does not manufacture store brands. e.t.browne drug co., inc., englewood cliffs, nj 07632 usa e.t. browne (u.k.) ltd. london n3 1xw england © 2017 e.t. browne drug co., inc. www.palmers.com made in usa f7386j117 clears acne blemishes gently removes impurities unclogs pores with sulfur net wt. 100 g/3.5 oz directions § clean the skin thoroughly before applying this product § cover the entire affected area with a thin layer and rinse thoroughly one to three times daily § because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times § if bothersome dryness or peeling occurs, reduce application to once a day or every other day 0000 00 bradford soap 1702001 bradford palmer - 7386
Further Questions:
Questions or comments? 1-800-378-6123 in the us