NDC 30815-0040 Hydro-q

Hydroquinone

NDC Product Code 30815-0040

NDC 30815-0040-1

Package Description: 1 TUBE in 1 BOX > 30 g in 1 TUBE

NDC Product Information

Hydro-q with NDC 30815-0040 is a a human prescription drug product labeled by Dermavance Pharmaceuticals. The generic name of Hydro-q is hydroquinone. The product's dosage form is gel and is administered via topical form.

Labeler Name: Dermavance Pharmaceuticals

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.

Hydro-q 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.

  • HYDROQUINONE 40 mg/g

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)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

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.

  • Melanin Synthesis Inhibitor - [EPC] (Established Pharmacologic Class)
  • Melanin Synthesis Inhibitors - [MoA] (Mechanism of Action)
  • Depigmenting Activity - [PE] (Physiologic Effect)

Product Labeler Information

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

Labeler Name: Dermavance Pharmaceuticals
Labeler Code: 30815
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: 12-08-2008 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".

* Please review the disclaimer below.

Hydro-q 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

Other

RX OnlyFOR EXTERNAL USE ONLY

Distributed by:DermAvance Pharmaceuticals, Malvern, PA 19355NDC 30815-0040-1P15132917-1I2430214

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:

Active Ingredient

Hydroquinone USP 4%OTHER INGREDIENTS: Purified water, Carbomer 940, Sodium Metabisulfite, Sodium Hydroxide, Methylparaben, Edetate Disodium.

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.

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.

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.

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 during 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 clothingKeep 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 personsOn 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

Precautions

See Warnings

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.

B. Nursing Mothers

It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when used by a nursing mother.

C. Pediatric Usage

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

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

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

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.

How Supplied

HYDRO-Q® (Hydroquinone 4%) Gel is supplied in a 30 g tube.NDC: 30815-0040-1

Storage And Handling

Store at controlled room temperature, between 15° and 30°C (59°and 86°F).

References

  • Denton C, Fitzpatrick TB, Lerner AB. Inhibition of melanin formation by chemical agents. J Invest Dermatology. 1952; 18: 119-135.Fitzpatrick TB, Jimbow K, Obata M, Panthak M. Mechanism of depigmentation by hydroquinone. J Invest Dermatology. 1974; 62: 436-449.Anderson RR, Parrish JA, Pitts D, Urbach F. UVA, Biological Effects of Ultraviolet Radiation With Emphasis on Human Responses to Longwave Ultraviolet. New York and London: Plenum Press; 1978: 151.

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