NDC 54111-170 Acne Control Superclean Body Wash Aha Bha Formula
Salicylic Acid Gel Topical

Product Information

What is NDC 54111-170?

The NDC code 54111-170 is assigned by the FDA to the product Acne Control Superclean Body Wash Aha Bha Formula which is a human over the counter drug product labeled by Bentley Laboratories, Llc. The generic name of Acne Control Superclean Body Wash Aha Bha Formula is salicylic acid. The product's dosage form is gel and is administered via topical form. The product is distributed in a single package with assigned NDC code 54111-170-50 250 ml in 1 bottle . 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 Code54111-170
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.		Acne Control Superclean Body Wash Aha Bha Formula
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 FormGel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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.		Bentley Laboratories, Llc
Labeler Code54111
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.		part333D
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.		03-01-2023
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.		12-31-2024
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 Acne Control Superclean Body Wash Aha Bha Formula?


Product Packages

NDC Code 54111-170-50

Package Description: 250 mL in 1 BOTTLE

Product Details

What are Acne Control Superclean Body Wash Aha Bha Formula 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 2 g/100mL - A compound obtained from the bark of the white willow and wintergreen leaves. It has bacteriostatic, fungicidal, and keratolytic actions.

Acne Control Superclean Body Wash Aha Bha Formula 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:

Acne Control Superclean Body Wash Aha Bha Formula 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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Acne Control Superclean Body Wash Aha Bha Formula 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



Otc - Active Ingredient



DRUG FACTS

Active Ingredients........... Salicylic Acid 2%


Otc - Purpose



Purpose ............... Acne Treatment


Indications & Usage



Uses: For the treatment of acne. Penetrates pores to eliminate most acne blemishes, whiteheads & blackheads. Helps prevent new acne blemishes, whiteheads & blackheads.


Dosage & Administration



Directions:  Lather with water and massage onto affected areas. Let sit for 30 to 60 seconds to maximize results. Rinse clean with warm water.


Warnings



Warnings: For external use only. When using this product skin irritation and dryness is 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.


Otc - Keep Out Of Reach Of Children



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


Inactive Ingredient



INACTIVE INGREDIENTS: WATER/AQUA/EAU, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL HYDROXYSULTAINE, DISTEARETH-75 IPDI, PROPANEDIOL, SODIUM LAUROAMPHOACETATE, GLYCERIN, GLYCOLIC ACID, COCAMIDOPROPYL BETAINE, PHENOXYETHANOL, SODIUM CHLORIDE, GLUCO-NOLACTONE, SODIUM HYDROXIDE, SODIUM GLUCONATE


Geologie Clear System Package Labeling



Geologie

CLEAR SYSTEM

Acne Control

Superclean

Body Wash

250 mL  8.4 fl oz

Geologie.com

Distributed by Geologie

New York, NY 10163

res


* Please review the disclaimer below.