141017 Hydrocortisone 0.5% / Hydroquinone 6% / Tretinoin 0.025% with NDC 72934-6226 is a a human prescription drug product labeled by Sincerus Florida, Llc. The generic name of 141017 Hydrocortisone 0.5% / Hydroquinone 6% / Tretinoin 0.025% is 141017 hydrocortisone 0.5% / hydroquinone 6% / tretinoin 0.025%. The product's dosage form is emulsion and is administered via topical form.
Labeler Name: Sincerus Florida, Llc
Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
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.
141017 Hydrocortisone 0.5% / Hydroquinone 6% / Tretinoin 0.025% 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.
- HYDROCORTISONE .5 g/100g
- HYDROQUINONE 6 g/100g
- TRETINOIN .025 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.
Pharmacological Class(es) What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.
- Corticosteroid - [EPC] (Established Pharmacologic Class)
- Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
- Melanin Synthesis Inhibitor - [EPC] (Established Pharmacologic Class)
- Melanin Synthesis Inhibitors - [MoA] (Mechanism of Action)
- Depigmenting Activity - [PE] (Physiologic Effect)
- Retinoid - [EPC] (Established Pharmacologic Class)
- Retinoids - [CS]
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: 07-02-2020 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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