NDC 51417-0005 Clearcalm Non-drying Acne Treatment

Salicylic Acid

NDC Product Code 51417-0005

NDC Code: 51417-0005

Proprietary Name: Clearcalm Non-drying Acne Treatment 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.

NDC Code Structure

  • 51417 - Ren Ltd.
    • 51417-0005 - Clearcalm Non-drying Acne Treatment

NDC 51417-0005-1

Package Description: 1 TUBE in 1 BOX > 15 mL in 1 TUBE

NDC Product Information

Clearcalm Non-drying Acne Treatment with NDC 51417-0005 is a a human over the counter drug product labeled by Ren Ltd.. The generic name of Clearcalm Non-drying Acne Treatment is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Ren Ltd.

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.

Clearcalm Non-drying Acne Treatment 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.

  • SALICYLIC ACID 5 mg/mL

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)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
  • WILLOW BARK (UNII: S883J9JDYX)
  • XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
  • ANHYDROXYLITOL (UNII: 8XWR7NN42F)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • XYLITOL (UNII: VCQ006KQ1E)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • FARNESOL (UNII: EB41QIU6JL)

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: Ren Ltd.
Labeler Code: 51417
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: 06-01-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Clearcalm Non-drying Acne Treatment Product Label Images

Clearcalm Non-drying Acne Treatment 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 0.5%

Purpose

AcneTreatment

Use

  • For the treatment of acne

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.

Keep Out Of Reach Of Children.

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

Directions

  • Clean the skin thoroughly before applying this product.cover the entire affected area with a thin layer one to three times daily.because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredients

Water (Aqua), Alcohol Denat.,Glycerin, Xanthan Gum, Maritime Pine Bark Extract, Caprylyl/Capryl Glucoside, Willow Bark Extract, Xylitylglucoside, Anhydroxylitol, Sodium Benzoate, Xylitol, Propanediol, Sandalwood Wood Oil, Potassium Sorbate, Sodium Cocoyl Glutamate, Glucose, Citric Acid, Glyceryl Caprylate, Polyglyceryl-6 Oleate, Thyme Leaf Oil, Chlorella Extract, Sodium Surfactin, Lactic Acid, Sodium Lactate, Farnesol

* Please review the disclaimer below.

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