NDC 42851-036 Zo Skin Health Pigment Control Plus Blending Creme Hydroquinone

Hydroquinone

NDC Product Code 42851-036

NDC CODE: 42851-036

Proprietary Name: Zo Skin Health Pigment Control Plus Blending Creme Hydroquinone What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydroquinone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Hydroquinone is used to lighten the dark patches of skin (also called hyperpigmentation, melasma, "liver spots," "age spots," freckles) caused by pregnancy, birth control pills, hormone medicine, or injury to the skin. This medicine works by blocking the process in the skin that leads to discoloration.

NDC Code Structure

  • 42851 - Zo Skin Health, Inc.

NDC 42851-036-30

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 30 mL in 1 BOTTLE, PLASTIC

NDC 42851-036-80

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 80 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Zo Skin Health Pigment Control Plus Blending Creme Hydroquinone with NDC 42851-036 is a a human prescription drug product labeled by Zo Skin Health, Inc.. The generic name of Zo Skin Health Pigment Control Plus Blending Creme Hydroquinone is hydroquinone. The product's dosage form is emulsion and is administered via topical form.

Labeler Name: Zo Skin Health, Inc.

Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

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.

Zo Skin Health Pigment Control Plus Blending Creme Hydroquinone 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 .04 g/mL

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.

  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
  • SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SODIUM SULFATE (UNII: 0YPR65R21J)
  • SODIUM SULFITE (UNII: VTK01UQK3G)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • WATER (UNII: 059QF0KO0R)
  • YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)

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: Zo Skin Health, Inc.
Labeler Code: 42851
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: 05-01-2018 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.

Zo Skin Health Pigment Control Plus Blending Creme Hydroquinone Product Label Images

Zo Skin Health Pigment Control Plus Blending Creme Hydroquinone 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

Blending crème containing 4% hydroquinone, the optimal concentration for melanin inhibition to correct skin pigmentation disorders.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618Made in USA with US & imported materialszoskinhealth.com | 905700

Dosage And Administration

Apply 2 pumps (1g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)

Warnings

Keep out of reach of children. Contains Sodium Metabisulfite, a sulfite that may cause serious allergic-type reactions, including anaphylactic symptoms (e.g., hives, itching) and life-threatening or less-severe asthmatic episodes in certain susceptible persons. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a poison control center right away.

Sunburn Alert

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterward.

Storage

Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.

Active Ingredient

Hydroquinone 4%

Inactive Ingredients

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, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Water, Yucca Schidigera Root Extract.

* Please review the disclaimer below.