NDC 11118-1209 Proactive Solution Cleaning Bar

Salicylic Acid

NDC Product Information

Proactive Solution Cleaning Bar with NDC 11118-1209 is a a human over the counter drug product labeled by Bradford Soap Works, Inc.. The generic name of Proactive Solution Cleaning Bar is salicylic acid. The product's dosage form is soap and is administered via topical form.

Labeler Name: Bradford Soap Works, Inc.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Proactive Solution Cleaning Bar Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SALICYLIC ACID 1 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
  • SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
  • SODIUM ISETHIONATE (UNII: 3R36J71C17)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bradford Soap Works, Inc.
Labeler Code: 11118
FDA Application Number: part358H What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-01-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Salicylic Acid Topical

Salicylic Acid Topical is pronounced as (sal'' i sil' ik as' id)

Why is salicylic acid topical medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions ...
[Read More]

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Proactive Solution Cleaning Bar Product Label Images

Proactive Solution Cleaning Bar Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Drug Factsactive Ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

Use

For the management of acne

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.

Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed get medical help or contact a Poison Control Center right away.

Stop Use And Ask A Doctor If

  • Irritation becomes severe.

Warnings

For external use only

Inactive Ingredients

Sodium cocoyl, isethionate, stearic acid, water, sodium isethionate, fragrance, cocamidopropyl hydroxysultaine, sodium chloride, galactoarabinan, disodium EDTA, pentasodium pentelate, titanium dioxide

When Using This Product

  • Do not use this prouct more than three times a dayskin 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.

Proactiv+ Product Label

Rodan & Fieldsproactive+Cleansing Body BarNet wt. 5.25 OX. 150 gsalicylic acid acne treatmentThis 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-comedogenicKEY INGREDIENTS:Salicylic Acid - an acne medicine that penetrates the follicle and encourages the shedding of dead skin cells, helping keep the pores clear of cellular debris. Clears up acne blemishes and helps prevent new ones from forming.Cleansing Agent - mild, high-foaminf cleansing ingredient derived from coconut oil, making Proactive+™ Cleansing Body Bar soap-free and surfactant free.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 to once a day. Can be used all over the face and body or targeted areas. If using during the day, follow with a sunscreen.Dist. by: Guthy-Renker LLC • PO Box 14383Palm Desert, CA 92255-4383 • proactivcomMade in the USA of Foreign and Domestic ComponentsProactive+ is a trademark in the United States and may be a trademark in other countriesPA00612

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