NDC 11118-1209 Proactive Solution Cleaning Bar
Salicylic Acid Soap Topical

Product Information

What is NDC 11118-1209?

The NDC code 11118-1209 is assigned by the FDA to the product Proactive Solution Cleaning Bar which is 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. The product is distributed in 2 packages with assigned NDC codes 11118-1209-1 150 g in 1 box , 11118-1209-2 79 g in 1 box . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code11118-1209
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Proactive Solution Cleaning Bar
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Salicylic Acid
Product Type 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.
Human Otc Drug
Dosage FormSoap - 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.
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.
Bradford Soap Works, Inc.
Labeler Code11118
FDA Application Number 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.
part358H
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-01-2010
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Proactive Solution Cleaning Bar?


Product Packages

NDC Code 11118-1209-1

Package Description: 150 g in 1 BOX

NDC Code 11118-1209-2

Package Description: 79 g in 1 BOX

Product Details

What are Proactive Solution Cleaning Bar Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • SALICYLIC ACID 1 g/100g - A compound obtained from the bark of the white willow and wintergreen leaves. It has bacteriostatic, fungicidal, and keratolytic actions.

Proactive Solution Cleaning Bar Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Proactive Solution Cleaning Bar Inactive Ingredients UNII Codes

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.

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Patient Education

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

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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 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.

Questions Or Comments?



Within US 1-800-950-4695


Proactiv+ Product Label



Rodan & Fields

proactive+

Cleansing Body Bar

Net wt. 5.25 OX. 150 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 - 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 14383

Palm Desert, CA 92255-4383 • proactivcom

Made in the USA of Foreign and Domestic Components

Proactive+ is a trademark in the United States and may be a trademark in other countries

PA00612


* Please review the disclaimer below.