NDC 64092-325 Acne

Salicylic Acid

NDC Product Code 64092-325

NDC CODE: 64092-325

Proprietary Name: Acne 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.

Non-Proprietary Name: Salicylic Acid 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

Product Characteristics

Color(s):
WHITE (C48325 - CLEAR)

NDC Code Structure

  • 64092 - Great Lakes Wholesale, Marketing And Sales Inc

NDC 64092-325-08

Package Description: 240 mL in 1 BOTTLE

NDC Product Information

Acne with NDC 64092-325 is a a human over the counter drug product labeled by Great Lakes Wholesale, Marketing And Sales Inc. The generic name of Acne is salicylic acid. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 199308.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Acne 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.


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)

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: Great Lakes Wholesale, Marketing And Sales Inc
Labeler Code: 64092
FDA Application Number: part333D 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: 06-30-2016 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 - NO 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".

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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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Acne Product Label Images

Acne 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

Description

GLW PERSONAL CARE SOLUTIONSDeep Cleaning AstringentSensitive SkinSalicylic Acid acne treatmentGentle yet effective cleanser that helps treat and prevent pimples.8 FL OZ (240 mL)

Otc - Active Ingredient

Active Ingedient PurposeSalicylic Acid 0.5%...............................................................Acne treatment

Otc - Purpose

Deep Cleaning acne treatment

Indications & Usage

For treatment of acne

Warnings

For external use only.Flammable, keep away from open flameWhen using this product, avoid contact with eyes. If contact occurs, immediately flush with water.Using other topical acne medications at the same time or immediately following use of this product may increase dryness of irritation of the skin. If this occurs, only one medication should be used, unless directed by a doctor.c

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Topical sensitive skin cleaning solution0.5% Salicylic Acid

Instructions For Use

  • Cleanse the skin thoroughly before applying medicationMoisten a cotton ball or padCover the entire affected area with a thin layer 1 to 3 times dailyBecause excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor..If bothersome drying or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredient

Water (aqua), alcohol, propylene glycol, glycerin, PEG-32, algae extract, DMDM hydantion, dimethicone propyl PG-betaine, sodium citrate, aloe barbadensis leaf exract, benzophenone-4, denatonium benzoate, fragrance, FD&C Blue No. 1.

* Please review the disclaimer below.