NDC 72934-1128 Imiquimod 5% / Salicylic Acid 30% / Tretinoin 0.1%

Imiquimod 5% / Salicylic Acid 30% / Tretinoin 0.1%

NDC Product Code 72934-1128

NDC CODE: 72934-1128

Proprietary Name: Imiquimod 5% / Salicylic Acid 30% / Tretinoin 0.1% 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: Imiquimod 5% / Salicylic Acid 30% / Tretinoin 0.1% 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.

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.

  • Drug uses not available
  • This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Tretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells.
  • This medication is used to treat certain types of growths on the skin. These are precancerous growths (actinic keratoses), a certain type of skin cancer (superficial basal cell carcinoma), and warts on the outside of the genitals/anus. Treating these conditions can decrease complications from them. Imiquimod belongs to a group of drugs called immune response modifiers. It is believed to work by helping to activate your immune system to fight these abnormal skin growths. This product is not recommended for use on children under 12 years of age unless specifically directed by your doctor.

NDC Code Structure

  • 72934 - Sincerus Florida, Llc
    • 72934-1128 - Imiquimod 5% / Salicylic Acid 30% / Tretinoin 0.1%

NDC 72934-1128-2

Package Description: 30 g in 1 BOTTLE, PUMP

NDC Product Information

Imiquimod 5% / Salicylic Acid 30% / Tretinoin 0.1% with NDC 72934-1128 is a a human prescription drug product labeled by Sincerus Florida, Llc. The generic name of Imiquimod 5% / Salicylic Acid 30% / Tretinoin 0.1% is imiquimod 5% / salicylic acid 30% / tretinoin 0.1%. The product's dosage form is gel and is administered via topical form.

Labeler Name: Sincerus Florida, Llc

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 Prescription 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.

Imiquimod 5% / Salicylic Acid 30% / Tretinoin 0.1% 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 30 g/100g
  • TRETINOIN .1 g/100g
  • IMIQUIMOD 5 g/100g

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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Retinoid - [EPC] (Established Pharmacologic Class)
  • Retinoids - [CS]
  • Increased Cytokine Activity - [PE] (Physiologic Effect)
  • Increased Cytokine Production - [PE] (Physiologic Effect)
  • Interferon Inducers - [MoA] (Mechanism of Action)

Product Labeler Information

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

Labeler Name: Sincerus Florida, Llc
Labeler Code: 72934
Marketing Category: UNAPPROVED DRUG OTHER - 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: 05-07-2019 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.

Imiquimod 5% / Salicylic Acid 30% / Tretinoin 0.1% Product Label Images