Hydroquinone 4%

Hydroquinone

Nivagen Pharmaceuticals, Inc.
Human Prescription Drug
NDC 75834-137

Hydroquinone 4% also known as Hydroquinone is a human prescription drug labeled by 'Nivagen Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Hydroquinone 4% is 75834-137. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Hydroquinone 4% drug includes Hydroquinone - 40 mg/g . The currest status of Hydroquinone 4% drug is Active.

Drug Information:

Drug NDC:	75834-137
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:	Hydroquinone 4%
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:	Nivagen Pharmaceuticals, Inc.
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:	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:	17 Aug, 2022
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, 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:	Nivagen Pharmaceuticals, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	197795
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
75834-137-01	1 TUBE in 1 CARTON (75834-137-01) / 28.4 g in 1 TUBE	17 Aug, 2022	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.

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Product Elements:

Hydroquinone 4% hydroquinone hydroquinone hydroquinone water butylated hydroxytoluene cetyl alcohol glycerin glycolic acid methylparaben propylparaben sodium lauryl sulfate sodium metabisulfite stearyl alcohol tetrahexyldecyl ascorbate .alpha.-tocopherol acetate, dl- edetate disodium

Drug Interactions:

Drug interactions patients are cautioned on concomitant use of medications that are known to be photosensitizing.

Indications and Usage:

Indications & usage hydroquinone usp, 4% skin bleaching cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Warnings:

Warnings contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. the overall prevalence of sulfite sensitivity in the general population is unknown and probably low. sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. since this product contains no sunscreen, an effective broad spectrum sun blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring. hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. if this condition occurs, discontinue treatment and consult your physician. the majority of patients developing this condition are black, but it may also occur in caucasians and hispanics.

General Precautions:

General precautions test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response further treatment is not advised. close patient supervision is recommended. hydroquinone is a skin bleaching agent which 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.

Dosage and Administration:

Dosage & administration hydroquinone usp, 4% skin bleaching cream should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. if no improvement is seen after 2 months of treatment, use of this product should be discontinued. there is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

Contraindications:

Contraindications prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. the safety of topical hydroquinone use during pregnancy or for children (12 years and under) has not been established.

Adverse Reactions:

Adverse reactions the following adverse reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. occasional hypersensitivity (localized contact dermatitis) may develop. if this occurs, the medication should be discontinued and the physician notified immediately.

Drug Interactions:

Drug interactions patients are cautioned on concomitant use of medications that are known to be photosensitizing.

Use in Pregnancy:

Pregnancy teratogenic effects: pregnancy category c - animal reproduction studies have not been conducted with topical hydroquinone. it is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. topical hydroquinone should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Pediatric use safety and effectiveness for 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 transient skin reddening and a mild burning sensation which does not preclude treatment.

Description:

Description each gram of hydroquinone usp, 4% skin bleaching cream contains 40 mg of hydroquinone usp, in a vanishing cream base of aqua (water), bht, cetyl alcohol, disodium edta, glycerin, glycolic acid, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, tetrahexyldecyl ascorbate, and tocopheryl acetate. chemically, hydroquinone is c 6 h 6 o 2 and has a molecular weight of 110.11. the chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is: structure.jpg

Clinical Pharmacology:

Clinical pharmacology topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (dopa) (denton, c. et al., 1952) 1 and suppression of other melanocyte metabolic processes (jimbow, k. et al., 1974) 2 . exposure to sunlight or ultraviolet light will cause repigmentation of bleached areas (parrish, j.a. et al., 1978) 3 .

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis & mutagenesis & impairment of fertility studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. the carcinogenic potential of hydroquinone in humans is unknown. published studies have demonstrated that hydroquinone is a mutagen and a clastogen. treatment with hydroquinone has resulted in positive findings for genetic toxicity in the ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay.

How Supplied:

How supplied hydroquinone usp, 4% skin bleaching cream is available as follows: 1 oz (28.4 g) tube (ndc 75834-137-01) storage hydroquinone usp, 4% skin bleaching cream should be stored at controlled room temperature (20-25Â°c) (68-77Â°f). darkening of this product is normal. this will not affect performance or safety. all prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. please note: this is not an orange book product and has not been subjected to fda therapeutic or other equivalency testing. no representation is made as to generic status or bioequivalency. each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein. references 1 denton c., lerner a.b., fitzpatrickt.b. inhibition of melanin Read more...

formation by chemical agents journal of investigative dermatology 1952, 18:119-135. 2 jimbow k., obata h., pathak m., fitzpatrick t.b. mechanism of depigmentation by hydroquinone journal of investigative dermatology 1974, 62:436-449. 3 parrish j.a., anderson r.r., urbach f., pitts d. uva, biological effects of ultraviolet radiation with emphasis on human responses to longwave ultraviolet plenum press, new york and london, 1978, p. 151. manufactured for: nivagen pharmaceuticals, inc. sacramento, ca 95827 usa toll free number: 1-877-977-0687 rev. 02/2022 hydroquinone usp, 4% skin bleaching cream

Information for Patients:

Information for patients 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 clothing. avoid contact with eyes and mucous membranes. keep this and all medications out of reach of children. in case of accidental ingestion, call a physician or a poison control center immediately.

Package Label Principal Display Panel:

Package label.principal display panel 28.4 g tube carton tube.jpg

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.