Olivia Quido Blemish Eraser

Hydroquinone

O Skin Care Llc
Human Prescription Drug
NDC 71421-801

Olivia Quido Blemish Eraser also known as Hydroquinone is a human prescription drug labeled by 'O Skin Care Llc'. National Drug Code (NDC) number for Olivia Quido Blemish Eraser is 71421-801. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Olivia Quido Blemish Eraser drug includes Hydroquinone - .02 g/g . The currest status of Olivia Quido Blemish Eraser drug is Active.

Drug Information:

Drug NDC:	71421-801
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:	Olivia Quido Blemish Eraser
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:	O Skin Care Llc
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 - .02 g/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:	04 May, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	04 May, 2027
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:	18 Dec, 2025
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:	O Skin Care LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
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
71421-801-30	1 BOTTLE, DISPENSING in 1 BOX (71421-801-30) / 48 g in 1 BOTTLE, DISPENSING	04 May, 2022	04 May, 2027	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:

Olivia quido blemish eraser hydroquinone carthamus tinctorius (safflower) oleosomes butylated hydroxytoluene iodopropynyl butylcarbamate c13-14 isoparaffin glycerin maltodextrin hyaluronic acid phenoxyethanol polyacrylamide (1500 mw) polysorbate 20 tetrahexyldecyl ascorbate water triethylene glycol aloe vera leaf diazolidinyl urea dimethyl isosorbide laureth-7 hydroquinone hydroquinone ceramide np trideceth-6 phosphate cetyl palmitate hexyl laurate kojic acid retinol 4-butylresorcinol cetyl peg/ppg-10/1 dimethicone (hlb 2) anhydrous citric acid polyglyceryl-4 isostearate

Drug Interactions:

7 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 blemish eraser cream treatment. patients are cautioned on concomitant use of medications that are known to be photosensitizing.

Indications and Usage:

Indications and usage 1.1indication blemish eraser is a combination of hydrocortisone (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and a tretinoin (a retinoid) that is indicated for the gradual bleaching of hyperpigmented skin conditions age and liver spots, freckles, and other unwanted areas of melanin hyperpigmentation, in the presence of measures for sun avoidance, including the use of sunscreen. 1.2 limitations of use the safety and efficacy of blemish eraser in pregnant women and nursing mothers have not been established. blemish eraser is a hydroquinone (a melanin synthesis inhibitor) that is indicated for the gradual bleaching of hyperpigmented skin conditions age and liver spots, freckles, and other unwanted areas of melanin hyperpigmentation, in the presence of measures for sun avoidance, including the use of sunscreen. (1)

Warnings and Cautions:

5 warnings and precautions 5.1 hypersensitivity if anaphylaxis, asthma or other clinically significantly hypersensitivity reactions occur, institute appropriate therapy and discontinue blemish eraser. allergic contact dermatitis may also occur. 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. 5.2 exogenous ochronosis blemish eraser contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy. most patients developing this condition are black, but it may also occur in caucasians and hispanics. 5.3. effects on endocrine system manifestations of cushingâs syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroid while tr Read more...

eatment. if hpa axis suppression is noted, the use of blemish eraser should be discontinued. recovery of hpa axis function generally occurs upon discontinuation of topical corticosteroids. 5.4 cutaneous reactions blemish eraser contains hydroquinone that may cause mild to moderate irritation. local irritation, such as skin reddening, peeling, mild burning sensation, dryness, and pruritus may be expected at the site of application. transient skin reddening or mild burning sensation does not preclude treatment. if a reaction suggests hypersensitivity or chemical irritation, discontinue use of the medication and call a doctor. patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentrations of alcohol and astringents, and other irritants or keratolytic drugs while on blemish eraser treatment. avoid use of medications that are known to be photosensitizing. if anaphylaxis, asthma or other clinically significantly hypersensitivity reactions occur, institute appropriate therapy and discontinue blemish eraser. allergic contact dermatitis may also occur. (5.1) blemish eraser contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy. (5.2)

Dosage and Administration:

2 dosage and administration gently wash the face and neck with a mild cleanser. rinse and pat the skin dry. apply a thin film of blemish eraser to the affected area once daily at night or as directed by a doctor. during the day, use o skin sunscreen spf-50, and wear protective clothing. avoid sunlight exposure to prevent repigmentation. blemish eraser is for topical use only. it is not for oral, ophthalmic, or intravaginal use. 2 dosage and administration gently wash the face and neck with a mild cleanser. rinse and pat the skin dry. apply a thin film of blemish eraser to the affected area once daily at night or as directed by a doctor. during the day, use o skin sunscreen spf-50, and wear protective clothing. avoid sunlight exposure to prevent repigmentation. blemish eraser is for topical use only. it is not for oral, ophthalmic, or intravaginal use.

Dosage Forms and Strength:

3 dosage forms and strengths cream, 2%. each gram of blemish eraser contains 20.0 mg of hydroquinone in a cream base. (3) cream, 2%. each gram of blemish eraser contains 20.0 mg of hydroquinone in a cream base. (3)

Contraindications:

Blemish eraser is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.. (4) blemish eraser is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.. (4)

Adverse Reactions:

No systemic adverse reactions have been reported. occasional hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately. in case of adverse reaction, call a doctor. (6) to report suspected adverse reactions, contact fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Drug Interactions:

Use in Specific Population:

8 use in specific populations 8.1 pregnancy teratogenic effects: pregnancy category c in general, use of drugs should be reduced to a minimum in pregnancy. if a patient has been inadvertently exposed to blemish eraser in pregnancy, she should be counseled on the risk of teratogenesis due to this exposure. the risk of teratogenesis due to topical exposure to blemish eraser may be considered low. however, exposure during the period of organogenesis in the first trimester is theoretically more likely to produce adverse outcome than in later pregnancy. 8.3 nursing mothers corticosteroids, when systemically administered, appear in human milk. it is not known whether topical application of blemish eraser could result in sufficient systemic absorption to produce detectable quantities of hydroquinone in human milk. because many drugs are secreted in human milk, caution should be exercised when blemish eraser is administered to a nursing woman. care should be taken to avoid contact between the Read more...

infant being nursed and blemish eraser. 8.4 pediatric use safety and effectiveness of blemish eraser in pediatric patients have not been established. 8.5 geriatric use in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. blemish eraser should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. (8.1)

Overdosage:

10 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:

11 description blemish eraser contains 2% of hydroquinone, usp, in a cream base for topical application. hydroquinone is a melanin synthesis inhibitor. it is prepared from the reduction of p-benzoquinone with sodium bisulfite. it occurs as fine white needles that darken on exposure to air. the chemical name for hydroquinone is: 1,4-benzenediol. the molecular formula is c6h6o2 and molecular weight is 110.11. hydroquinone has the following structural formula: blemish eraser contains active: 2% (20 mg) hydroquinone. inactive: 4-butylresorcinol, aloe barbadensis leaf juice, bht, c13-14 isoparaffin, caprylic/capric triglyceride, carthamus tinctorius (safflower) oleosomes, ceramide-np, cetyl palmitate, cetyl peg/ppg-10/1 dimethicone, citric acid, diazolidinyl urea, dimethyl isosorbide, glycerin, hexyl laurate, iodopropynyl butylcarbamate, kojic acid, laureth-23, laureth-7, maltodextrin, phenoxyethanol, polyacrylamide, polyglyceryl-4 isostearate, polysorbate 20, retinol, silica, sodium hyaluronate, sodium hydroxide, tetrahexyldecyl ascorbate, tocopheryl acetate, trideceth-6 phosphate, triethylene glycol, water/aqua.

Clinical Pharmacology:

12 clinical pharmacology 12.1 mechanism of action the mechanism of action of the active ingredients in blemish eraser in the treatment of melasma is unknown.

Nonclinical Toxicology:

13 nonclinical toxicology 13.1 carcinogenesis, mutagenesis, impairment of fertility carcinogenesis studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. the carcinogenic potential of hydroquinone in humans is unknown. mutagenesis mutagenicity studies were not conducted with this combination of active ingredients. 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. tretinoin has been shown to be negative for mutagenesis in the ames assay. additional information regarding the genetic toxicity potential of tretinoin is not available. impairment of fertility no studies of fertility and early embryonic toxicity of this drug product has been performed.

How Supplied:

16 how supplied blemish eraser is light yellow in color, and supplied in 48 g jar, ndc 71421-801-30.

Package Label Principal Display Panel:

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Comments/ Reviews:

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