Zo Skin Health Pigment Control Program Plus Hydroquinone

Hydroquinone


Zo Skin Health, Inc.
Human Prescription Drug
NDC 42851-184
Zo Skin Health Pigment Control Program Plus Hydroquinone also known as Hydroquinone is a human prescription drug labeled by 'Zo Skin Health, Inc.'. National Drug Code (NDC) number for Zo Skin Health Pigment Control Program Plus Hydroquinone is 42851-184. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Zo Skin Health Pigment Control Program Plus Hydroquinone drug includes . The currest status of Zo Skin Health Pigment Control Program Plus Hydroquinone drug is Active.

Drug Information:

Drug NDC: 42851-184
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: Zo Skin Health Pigment Control Program Plus Hydroquinone
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: Zo Skin Health, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Kit
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:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:
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: 09 Mar, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 Jun, 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:ZO Skin Health, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1235391
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.
UNII:
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.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
42851-184-601 KIT in 1 CARTON (42851-184-60) * 1 PATCH in 1 JAR * 30 mL in 1 BOTTLE, PLASTIC * 30 mL in 1 BOTTLE, PLASTIC * 30 mL in 1 BOTTLE, PUMP * 16.2 g in 1 JAR * 60 mL in 1 TUBE09 Mar, 2021N/ANo
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:

Zo skin health pigment control program plus hydroquinone hydroquinone zo skin health gentle cleanser water sodium laureth-3 sulfate cocamidopropyl betaine sodium lauroyl oat amino acids glycerin green tea leaf limonene, (+/-)- linalool, (+/-)- sodium chloride butylene glycol ethylhexylglycerin phenoxyethanol fd&c blue no. 1 d&c red no. 33 zo skin health exfoliating polish polyethylene glycol 400 sodium bicarbonate magnesium oxide diethylene glycol monoethyl ether glycerin butylene glycol oleth-20 trihydroxystearin glyceryl monostearate peg-100 stearate mineral oil water .alpha.-tocopherol acetate, dl- tea tree oil soy sterol limonene, (+/-)- linalool, (+/-)- ascorbyl palmitate vitamin a palmitate stearyl glycyrrhetinate tetrahexyldecyl ascorbate medium-chain triglycerides linoleic acid lecithin, soybean phenoxyethanol d&c green no. 6 zo skin health complexion renewal pads alcohol salicylic acid sodium hydroxide glycolic acid phenoxyethanol sodium carbonate edetate disodium anhydrous denatonium benzoate .beta.-citronellol, (r)- .alpha.-hexylcinnamaldehyde linalool, (+/-)- urea barley butylene glycol sodium chloride tert-butyl alcohol pterocarpus soyauxii wood green tea leaf limonene, (+)- water propylene glycol plantago lanceolata leaf phellodendron amurense bark crithmum maritimum zo skin health pigment control creme hydroquinone hydroquinone water ascorbic acid ascorbyl palmitate caprylyl glycol cetyl alcohol chlorphenesin dioscorea villosa tuber edetate disodium anhydrous glycerin glycolic acid phenoxyethanol quillaja saponaria bark smilax aristolochiifolia root sodium hydroxide sodium lauryl sulfate sodium metabisulfite sodium sulfite stearyl alcohol .alpha.-tocopherol acetate yucca schidigera root hydroquinone hydroquinone zo skin health pigment control plus blending creme hydroquinone hydroquinone ascorbic acid ascorbyl palmitate caprylyl glycol cetyl alcohol chlorphenesin dioscorea villosa tuber edetate disodium anhydrous ethylhexyl palmitate glycerin glycolic acid palmitic acid phenoxyethanol phenyl trimethicone quillaja saponaria bark smilax aristolochiifolia root sodium hydroxide sodium lauryl sulfate sodium metabisulfite sodium sulfite stearyl alcohol .alpha.-tocopherol acetate, dl- water yucca schidigera root hydroquinone hydroquinone zo skin health daily power defense pentylene glycol powdered cellulose retinol limonene, (+)- cetostearyl alcohol c12-20 alkyl glucoside lactose, unspecified form anhydrous lactose butylene glycol hypromellose, unspecified palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 caprylyl glycol steareth-20 .alpha.-tocopherol acetate cyclomethicone 5 glycerin cetearyl isononanoate cyclomethicone 6 phenoxyethanol ext. d&c violet no. 2 edetate disodium anhydrous sodium hydroxide ethylhexylglycerin vitamin a palmitate hexylene glycol arabidopsis thaliana ultramarine blue 1,2-hexanediol c14-22 alcohols cetearyl glucoside carbomer homopolymer, unspecified type water

Drug Interactions:

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

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

Indications and Usage:

Indications and usage pigment control creme is indicated in the gradual bleaching of hyperpigmentation, skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Indications and usage for the gradual bleaching of hyperpigmented skin conditions such as cholasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Warnings:

Warnings hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. the physician should be familiar with the contents of this insert before prescribing or dispensing this product. 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. avoid unnecessary sun exposure, use an effective broad-spectrum sunscreen agent or protective clothing should be worn to cover bleached skin to prevent re-pigmentation 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. avoid contact with eyes and mucous membra
nes. keep out of reach of children. in case of accidental ingestion, call a physician or a poison control center immediately.

Warnings hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. the physician should be familiar with the contents of this insert before prescribing or dispensing this product. 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. avoid unnecessary sun exposure, use an effective broad-spectrum sunscreen agent or protective clothing should be worn to cover bleached skin to prevent re-pigmentation 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. avoid contact with eyes and mucous membra
nes. keep out of reach of children. in case of accidental ingestion, call a physician or a poison control center immediately.

Dosage and Administration:

Drug dosage and administration a thin layer of pigment control creme (hydroquinone usp, 4%) should be applied to the affected area twice daily or as directed by a physician. if no improvement is seen after 8-12 weeks 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.

Drug dosage and administration a thin application of pigment control + blending creme should be applied to the affected area twice daily or as directed by a physician. consult product label for instructions on whether to rub in or not. there is no recommendation for children under 12 years of age except under the advice and supervision of a physician.

Contraindications:

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

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

Adverse Reactions:

Adverse reactions the following 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.

Adverse reactions the following 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.

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

Use in Pregnancy:

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.

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.

Pediatric use safety and effectiveness for pediatric patients below the age of 12 years have not been established.

Overdosage:

Overdosage there have been no system 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.

Overdosage there have been no system 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 hydroquinone is 1,4-benzendiol, with a chemical formula of c6h6o2 and a molecular weight of 110.11. the structural formula is: each gram of pigment control creme (hydroquinone usp, 4%) contains hydroquinone usp 40 mg/gm in a base of purified water, ascorbic acid, ascorbyl palmitate, beta-glucan, caprylyl glycol, cetyl alcohol, chlorphenesin, dioscorea villosa (wild yam) root extract, disodium edta, glycerin, glycolic acid, phenoxyethanol, quillaja saponaria bark extract, smilax aristolochiifolia root extract, sodium hydroxide, sodium lauryl sulfate, sodium metabisulfite, sodium sulfite, stearyl alcohol, tocopheryl acetate, yucca schidigera root extract. chemical structure

Description hydroquinone is 1,4-benzendiol, with a chemical formula of c6h6o2 and a molecular weight of 110.11. the structural formula is: each gram of pigment control + blending creme contains hydroquinone usp 40mg/gm in a base of ascorbic acid, ascorbyl palmitate, beta-glucan, caprylyl glycol, cetyl alcohol, chlorphenesin, dioscorea villosa (wild yam) root extract, disodium edta, ethylhexyl palmitate, glycerin, glycolic acid, palmitic acid, phenoxyethanol, phenyl trimethicone, purified water, quillaja saponaria bark extract, smilax aristolochiifolia root extract, sodium hydroxide, sodium lauryl sulfate, sodium metabisulfite, sodium sulfite, stearyl alcohol, tocopheryl acetate, yucca schidigera root extract. chemical structure

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) and suppression of other melanocyte metabolic processes. exposure to sunlight or ultraviolet light will cause re-pigmentation of bleached areas, which may be prevented by the use of the sunscreen agents.

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) and suppression of other melanocyte metabolic processes. exposure to sunlight or ultraviolet light will cause re-pigmentation of bleached areas, which may be prevented by the use of the sunscreen agents.

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.

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.

How Supplied:

How supplied pigment control creme (hydroquinone usp, 4%) is available as follows: 2.7 fl. oz. (80 ml) bottle / ndc 42851-037-80 1.0 fl oz/30 ml bottle / ndc 42851-037-30 storage store at controlled room temperature: 15°-30°c (59°-86°f)

How supplied pigment control + blending creme (hydroquinone usp, 4%) is available as follows: 2.7 fl. oz. (80 ml) bottle / ndc 42851-036-80 1.0 fl. oz (30 ml) bottle / ndc 42851-036-30 storage store at controlled room temperature: 15°-30°c (59°-86°f)

Package Label Principal Display Panel:

Principal display panel - kit carton zo ® skin health by zein obagi md pigment control program + hydroquinone ndc 42851-184-60 gentle cleanser 60 ml / 2 fl. oz. exfoliating polish net wt. 16.2 g / 0.57 oz. complexion renewal pads 30 pads pigment control crÈme 30 ml / 1.0 fl. oz. daily power defense 30 ml / 1 fl. oz. pigment control + blending creme 30 ml / 1 fl. oz. us pigment control + hydroquinone kit uc.jpg


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