Proactive Solution Cleaning Bar
Salicylic Acid
Bradford Soap Works, Inc.
Human Otc Drug
NDC 11118-1209Proactive Solution Cleaning Bar also known as Salicylic Acid is a human otc drug labeled by 'Bradford Soap Works, Inc.'. National Drug Code (NDC) number for Proactive Solution Cleaning Bar is 11118-1209. This drug is available in dosage form of Soap. The names of the active, medicinal ingredients in Proactive Solution Cleaning Bar drug includes Salicylic Acid - 1 g/100g . The currest status of Proactive Solution Cleaning Bar drug is Active.
Drug Information:
| Drug NDC: | 11118-1209 |
| 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: | Proactive Solution Cleaning Bar |
| 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: | 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: | SALICYLIC ACID - 1 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: | 01 Sep, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 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: | 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: | Bradford Soap Works, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 205162
|
| 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 |
|---|
| 11118-1209-1 | 150 g in 1 BOX (11118-1209-1) | 01 Sep, 2010 | N/A | No |
| 11118-1209-2 | 79 g in 1 BOX (11118-1209-2) | 01 Mar, 2015 | 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:
Proactive solution cleaning bar salicylic acid salicylic acid salicylic acid water stearic acid sodium chloride titanium dioxide edetate disodium pentasodium pentetate sodium cocoyl isethionate sodium isethionate cocamidopropyl betaine low density polyethylene
Indications and Usage:
Use for the management of acne
Warnings:
Warnings for external use only
When Using:
When using this product do not use this prouct more than three times a day skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time. avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water.
Dosage and Administration:
Directions sensitivity test for a new user: apply product sparingly to one or two small affected areas during the first 3 days. if no discomfort occurs, follow the directions stated below. because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application to once daily or every other day.
Package Label Principal Display Panel:
Proactiv cleansing body bar 7 35786 02037 8 drug facts active ingredientâ¦â¦â¦purpose salicylic acid 1%...acne treatment use for management of acne warnings for external use only when using this product ⢠do not use this product more than three times per day. ⢠skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time. ⢠avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water. stop use and ask a doctor if â¢irritation becomes severe keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. drug facts (continued) directions ⢠sensitivity test for a new user: apply product sparingly to one or two small affected areas during the first 3 days. if no discomfort occurs, follow the directions stated below. ⢠apply a small amount to dampened skin. ⢠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 daily if needed or as directed by a doctor. ⢠if bothersome dryness or peeling occurs, reduce application to once a day or every other day. proactiv ® cleansing body bar net wt. 2.7 oz. 79 g salicylic acid acne treatment this soap-free cleansing bar contains acne-fighting salicylic acid to help clear pores as well as treat and help prevent new acne blemishes on the face and body. sulfate-free ⢠dermatologist tested ⢠non-comedogenic key ingredients: salicylic acid â an acne medicine that penetrates the follicle and encourages the shedding of dead skin cells, helping keep the pores clear of cellular debris. cleans up acne blemishes and helps prevent new ones from forming. cleansing agent â mild, high-foaming cleansing ingredient derived from coconut oil, making proactive cleansing body bar soap-free and surfactant-free. distributed by the proactiv company llc ⢠100 n sepulveda blvd., el segundo, ca 90245 ⢠proactive.com made in the usa of foreign and domestic components ⢠proactiv is a trademark of the the proactive company sanl pa01113 tips wet hands and work bar until it lathers. apply to dampened skin, gently massaging in an upward circular motion. rinse thoroughly with warm water and pat dry with a clean towel. can be used twice daily. if bothersome dryness or peeling occurs, reduce application use to once a day. can be used all over the face and body or on targeted areas. if using during the day, follow with a sunscreen. proactiv body bar
Further Questions:
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