Triderma
Hydroquinone, Tretinoin, Fluocinolone Acetonide
Pella Pharmaceutical Co. Ltd
Human Prescription Drug
NDC 82160-123Triderma also known as Hydroquinone, Tretinoin, Fluocinolone Acetonide is a human prescription drug labeled by 'Pella Pharmaceutical Co. Ltd'. National Drug Code (NDC) number for Triderma is 82160-123. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Triderma drug includes Fluocinolone Acetonide - 3 mg/30g Hydroquinone - 1200 mg/30g Tretinoin - 15 mg/30g . The currest status of Triderma drug is Active.
Drug Information:
| Drug NDC: | 82160-123 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Triderma |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hydroquinone, Tretinoin, Fluocinolone Acetonide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pella Pharmaceutical Co. Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | FLUOCINOLONE ACETONIDE - 3 mg/30g
HYDROQUINONE - 1200 mg/30g
TRETINOIN - 15 mg/30g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 12 Jan, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Pella Pharmaceutical Co. Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1191262
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175576
N0000175450
N0000175851
N0000175854
N0000175850
N0000175607
M0018962
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 0CD5FD6S2M
XV74C1N1AE
5688UTC01R
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Corticosteroid Hormone Receptor Agonists [MoA]
Melanin Synthesis Inhibitors [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Corticosteroid [EPC]
Melanin Synthesis Inhibitor [EPC]
Retinoid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Depigmenting Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Retinoids [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
Depigmenting Activity [PE]
Melanin Synthesis Inhibitor [EPC]
Melanin Synthesis Inhibitors [MoA]
Retinoid [EPC]
Retinoids [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82160-123-01 | 1 TUBE in 1 CARTON (82160-123-01) / 30 g in 1 TUBE | 12 Jan, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Triderma hydroquinone, tretinoin, fluocinolone acetonide tretinoin tretinoin fluocinolone acetonide fluocinolone acetonide hydroquinone hydroquinone yellow to faint yellow
Drug Interactions:
Drug interactions patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentration of alcohol and astringent, and other irritants or keratolytic drugs while on tridema treatment. patients are cautioned on concomitant use of medications that are known to be photosensitizing.
Indications and Usage:
Indications triderma is indicated for the short-term intermittent treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.
Warnings:
Warnings triderma contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and lifeÂthreatening asthmatic episodes in susceptible people. triderma contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, whose occurrence should prompt discontinuation of therapy. the majority of patients developing this condition are black, but it may also occur in caucasians and hispanics. cutaneous hypersensitivity to the active ingredients of triderma has been reported in the literature. in a patch test study to determine sensitization potential in 221 healthy volunteers, three volunteers developed sensitivity reactions to the product or its components.
General Precautions:
This is a medicament medicament is a product which affects your health and its consumption contrary to instructions is dangerous for you. strictly follow the doctor's prescription, the method of use and the instruction of the pharmacist who sold the medicament. the doctor and the pharmacist are experts in medicine, its benefits and risks. do not by yourself interrupt the period of treatment prescribed for you. do not repeat the same prescription without consulting your doctor. keep medicament out of reach of children.
Dosage and Administration:
Dosage and administration triderma should be applied once daily at night. it should be applied at least 30 minutes before bedtime. gently wash the fuce and neck with a mild cleanser. rinse and pat the skin dry. apply a thin film of the cream to the hyper pigmented areas of melasma including about 1/2 inch of normal appearing skin surrounding each lesion. rub lightly and uniformly into the skin. do not use occlusive dressing. during the day, use a sunscreen of spf 30, and wear protective clothing. avoid sunlight exposure. patients may use moisturizers and/or cosmetics during the day. duration of action: triderma cream is for short-term (up to 8 weeks) treatment of moderate to severe melasma of the face. it is not for longÂterm (more than 8 weeks) or maintenance (continuous) treatment of melasma. milder forms of melasma may not need treatment with medicine. melasma can also be managed by staying out of the sun or by stopping the use of birth control methods that involve hormones.
Contraindications:
Contraindications triderma is contraindicated in individuals with a history of hypersensitivity, allergy, or intolerance to this product or any of its components.
Adverse Reactions:
Side effects the following local adverse reactions have been reported infrequently with topical corticosteroids. they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. these reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneifom, eruptions, hypopigmentations, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
Drug Interactions:
Drug interactions patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentration of alcohol and astringent, and other irritants or keratolytic drugs while on tridema treatment. patients are cautioned on concomitant use of medications that are known to be photosensitizing.
Use in Pregnancy:
Pregnancy teratogenic effects: pregnancy category c. triderma cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. it is difficult to interpret the animal studies on teratogenicity with tridrema cream, because the availability of the dermal applications in these studies cannot be assured, and comparison with clinical dosing is not possible. there are no adequate and well-controlled studies in pregnant women. triderma should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Overdosage:
Overdosage no information provided.
Description:
Properties fluocinolone acetonide is a synthetic fluorinated corticosteroid for topical dermatological use and is classified therapeutically as an antiÂ-inflammatory. it is a white crystalline powder that is odorless and stable in light. hydroquinone is classified therapeutically as a de-pigmenting agent. it is prepared from the reduction of p-benzoquinone with sodium bisulfite. it occurs as fine white needles that darken on exposure to air. tretinoin is all-trans-retinoic acid formed from the oxidation of the aldehyde group of retinene to a carboxyl group. it occurs as yellow to light-orange crystals or crystalline powder with a characteristic odor of ensilage. it is highly reactive to light and moisture. tretinoin is classified therapeutically as a keratolytic.
How Supplied:
How supplied 30 g packs.
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