Hydro-q
Hydroquinone
Dermavance Pharmaceuticals
Human Prescription Drug
NDC 30815-0040Hydro-q also known as Hydroquinone is a human prescription drug labeled by 'Dermavance Pharmaceuticals'. National Drug Code (NDC) number for Hydro-q is 30815-0040. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Hydro-q drug includes Hydroquinone - 40 mg/g . The currest status of Hydro-q drug is Active.
Drug Information:
| Drug NDC: | 30815-0040 |
| 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: | Hydro-q |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dermavance Pharmaceuticals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | HYDROQUINONE - 40 mg/g
|
| 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: | 08 Dec, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Dec, 2025 |
| 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, 2024 |
| 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: | Dermavance Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 310926
|
| 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: | N0000175851
N0000175854
N0000175850
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | XV74C1N1AE
|
| 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: | 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: | Melanin Synthesis Inhibitor [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: | Depigmenting Activity [PE]
Melanin Synthesis Inhibitor [EPC]
Melanin Synthesis Inhibitors [MoA]
|
| 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 |
|---|
| 30815-0040-1 | 1 TUBE in 1 BOX (30815-0040-1) / 30 g in 1 TUBE | 08 Dec, 2008 | 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:
Hydro-q hydroquinone hydroquinone hydroquinone water carbomer homopolymer type c (allyl pentaerythritol crosslinked) sodium metabisulfite sodium hydroxide methylparaben edetate disodium
Indications and Usage:
Indications and usage hydro-q ® is indicated for the gradual bleaching of hyperpigmented skin conditions such as chlosma, melasma, freckles, senile lentigines and areas of melanin hyperpigmentation.
Warnings:
Warnings caution: hydroquinone is a depigmenting agent that may produce unwanted cosmetic effects if not used as directed. the physician should be familiar with the contents of this insert before prescribing or dispensing this medication. test for skin sensitivity before using hydro-q ® by applying a small amount of the gel to an unbroken patch of skin and check within 24 hours. minor redness is not a contraindication but where there is itching and vesicle formation or excessive inflammatory response further treatment is not advised. close patient supervision is recommended. contact with the eyes should be avoided. if no lightening effect is noted after 2 months of treatment the use of hydro-q ® should be discontinued. hydro-q ® is formulated for the treatment of dyschromia and should not be used for the prevention of sunburn. sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. to prevent repigmentation duri
Read more...ng treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen spf 15 or greater) or by use of protective clothing keep this and all medications out of reach of children. in case of accidental ingestion, contact a physician or a poison control center immediately. warning: contains sodium metabisulfite, a sulfite that may cause serious allergic reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons on rare occasions, a gradual blue-black darkening of the skin may occur, in which case, use of hydro-q ® should be discontinued and a physician contacted immediately
Dosage and Administration:
Dosage and adminstration hydro-q ® should be applied to the affected areas twice daily, morning and before bedtime or as directed by a physician. during and after the use of hydro-q ® , sun exposure should be limited and a sunscreen agent or protective clothing should be used to cover up the treated areas to prevent regimentation. if no lightening effect is noted after two months of treatment, use of hydro-q ® should be discontinued. there is no recommended dosage for children under the age of 12 years of age except under the advice and supervision of a physician.
Contraindications:
Contraindications hydro-q ® is contraindicated in any patient that has a prior history of sensitivity or allergic reaction to hydroquinone or any of the other ingredients. the safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.
Adverse Reactions:
Adverse reactions no systemic reactions have been reported. occasional cutaneous hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately
Use in Pregnancy:
A. pregnancy category c animal reproduction studies have not been conducted with topical hydroquinone. it is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman, or can affect reproductive capacity.
Pediatric Use:
C. pediatric usage safety and effectiveness in pediatric patients below the age of 12 years have not been established.
Overdosage:
Overdosage there have been no systemic reactions reported from the use of topical hydroquinone. however, treatment should be limited to relatively small areas of the body at one time, since some patients experience a skin reddening and a mild burning sensation that does not preclude treatment
Description:
Hydro-q ® contains hydroquinone usp 4%. hydroquinone is 1, 4-benzenediol {cas 123-31-91}. hydroquinone is structurally related to monobenzone. hydroquinone occurs as fine white needles. the drug is freely soluble in water and in alcohol and has a pka of 9.96. chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is c6h6o2; the molecular weight is 110.1. the structural formula is: chemical structure
Clinical Pharmacology:
Clinical pharmacology topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic hydroquinone. oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) 1 and suppression of other melanocyte metabolic processes. exposure to sunlight or ultraviolet light will cause regimentation of the bleached areas.
How Supplied:
How supplied hydro-q ® (hydroquinone 4%) gel is supplied in a 30 g tube. ndc: 30815-0040-1 store at controlled room temperature, between 15° and 30°c (59°and 86°f).
Package Label Principal Display Panel:
Principal display panel - 30 g tube box ndc 30815-0040-1 rx only hydro-q 4% gel ® (hydroquinone 4%) gel® skin bleaching gel dermavance ® advanced skin care www.dermavance.com 30 g principal display panel - 30 g tube box