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  4. NDC Product Code: 83325-001 2% Salicylic Acid Body Wash For Acne Prone Skin

NDC 83325-001 2% Salicylic Acid Body Wash For Acne Prone Skin

Glycerin,Sodium Pca,Salicylic Acid,Kaolin Clay,Vitamin B5,Vitamin E,Rosa Canina Fruit Oil - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83325-001?
  4. 2% Salicylic Acid Body Wash For Acne Prone Skin Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
83325-001
Proprietary Name:
2% Salicylic Acid Body Wash For Acne Prone Skin
Non-Proprietary Name: [1]
Glycerin, Sodium Pca, Salicylic Acid, Kaolin Clay, Vitamin B5, Vitamin E, Rosa Canina Fruit Oil
Substance Name: [2]
.alpha.-tocopherol; Glycerin; Kaolin; Pantothenic Acid; Rosa Canina Fruit Oil; Salicylic Acid; Sodium Pyrrolidone Carboxylate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Volans Epic Llc
    Labeler Code:
    83325
    Product Label ID:
    50463444-e09d-4761-acb0-90876f665801
    FDA Application Number: [6]
    M016
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    04-06-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Code Structure Chart

    Product Details

    What is NDC 83325-001?

    The NDC code 83325-001 is assigned by the FDA to the product 2% Salicylic Acid Body Wash For Acne Prone Skin which is a human over the counter drug product labeled by Volans Epic Llc. The generic name of 2% Salicylic Acid Body Wash For Acne Prone Skin is glycerin, sodium pca, salicylic acid, kaolin clay, vitamin b5, vitamin e, rosa canina fruit oil. The product's dosage form is liquid and is administered via topical form. The product is distributed in a single package with assigned NDC code 83325-001-01 472 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 and RxNorm crosswalk.

    What are the uses for 2% Salicylic Acid Body Wash For Acne Prone Skin?

    Squeeze a generous amount and massage gently on your dampened body. Rinse thoroughly with warm water.

    What are 2% Salicylic Acid Body Wash For Acne Prone Skin 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.
    • .ALPHA.-TOCOPHEROL 5 mg/472mL - A natural tocopherol and one of the most potent antioxidant tocopherols. It exhibits antioxidant activity by virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus. It has four methyl groups on the 6-chromanol nucleus. The natural d form of alpha-tocopherol is more active than its synthetic dl-alpha-tocopherol racemic mixture.
    • GLYCERIN 50 mg/472mL
    • KAOLIN 20 mg/472mL - The most common mineral of a group of hydrated aluminum silicates, approximately H2Al2Si2O8-H2O. It is prepared for pharmaceutical and medicinal purposes by levigating with water to remove sand, etc. (From Merck Index, 11th ed) The name is derived from Kao-ling (Chinese: "high ridge"), the original site. (From Grant & Hackh's Chemical Dictionary, 5th ed)
    • PANTOTHENIC ACID 10 mg/472mL - A butyryl-beta-alanine that can also be viewed as pantoic acid complexed with BETA ALANINE. It is incorporated into COENZYME A and protects cells against peroxidative damage by increasing the level of GLUTATHIONE.
    • ROSA CANINA FRUIT OIL 1 mg/472mL
    • SALICYLIC ACID 20 mg/472mL - A compound obtained from the bark of the white willow and wintergreen leaves. It has bacteriostatic, fungicidal, and keratolytic actions.
    • SODIUM PYRROLIDONE CARBOXYLATE 20 mg/472mL

    Which are 2% Salicylic Acid Body Wash For Acne Prone Skin UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are 2% Salicylic Acid Body Wash For Acne Prone Skin 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. The UNII codes for the inactive ingredients in this product are:

    Which are the Pharmacologic Classes for 2% Salicylic Acid Body Wash For Acne Prone Skin?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".