NDC 10742-1234 Phisoderm Clean Anti-blemish Body Wash

Salicylic Acid

NDC Product Code 10742-1234

NDC CODE: 10742-1234

Proprietary Name: Phisoderm Clean Anti-blemish Body Wash 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.

NDC Code Structure

  • 10742 - The Mentholatum Company

NDC 10742-1234-1

Package Description: 295 mL in 1 BOTTLE

NDC Product Information

Phisoderm Clean Anti-blemish Body Wash with NDC 10742-1234 is a a human over the counter drug product labeled by The Mentholatum Company. The generic name of Phisoderm Clean Anti-blemish Body Wash is salicylic acid. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1423494 and 562600.

Dosage Form: Gel - 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.

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.

Phisoderm Clean Anti-blemish Body Wash 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)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
  • CHAMOMILE (UNII: FGL3685T2X)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
  • DIHYDROXYPROPYLTRIMONIUM (UNII: 925G44QFFO)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: The Mentholatum Company
Labeler Code: 10742
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: 07-02-2021 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: 12-31-2022 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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Phisoderm Clean Anti-blemish Body Wash Product Label Images

Phisoderm Clean Anti-blemish Body Wash 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

Active Ingredient

Salicylic acid 2%

Purpose

Acne treatment

Uses

  • •for the treatment of acne •helps prevent new acne pimples from forming

Warnings

For external use only

When Using This Product

  • •avoid contact with eyes. If contact occurs, flush thoroughly with water. •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.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • •use daily in the shower or bath •massage over wet skin with a washcloth or body puff, concentrating on areas prone to breakouts •rinse thoroughly

Inactive Ingredients

Water, sodium C14-16 olefin sulfonate, disodium cocoamphodiacetate, cocamidopropyl betaine, sodium methyl cocoyl taurate, glycerin, acrylates copolymer, aloe barbadensis leaf juice, butylene glycol, caprylyl/capryl glucoside, chamomilla recutita (matricaria) flower extract, citric acid, disodium EDTA, hydroxyphenyl propamidobenzoic acid, hydroxypropyltrimonium hyaluronate, melaleuca alternifolia (tea tree) leaf oil, pentylene glycol, potassium sorbate, sodium benzoate, sodium chloride, sodium hydroxide, tocopheryl acetate [vitamin E]

Questions?

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

* Please review the disclaimer below.