NDC 56152-4004 Divine Derrier Skin Bleaching Cream

Hydroquinone

NDC Product Code 56152-4004

NDC Code: 56152-4004

Proprietary Name: Divine Derrier Skin Bleaching Cream 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.


Code Structure
  • 56152 - Cosmetic Enterprises Ltd
    • 56152-4004 - Divine Derrier Skin Bleaching Cream

NDC 56152-4004-1

Package Description: 50 mL in 1 JAR

NDC Product Information

Divine Derrier Skin Bleaching Cream with NDC 56152-4004 is a a human over the counter drug product labeled by Cosmetic Enterprises Ltd. The generic name of Divine Derrier Skin Bleaching Cream is hydroquinone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cosmetic Enterprises Ltd

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc 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.


Divine Derrier Skin Bleaching Cream 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 2 g/100mL

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)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ALLANTOIN (UNII: 344S277G0Z)
  • FERULIC ACID (UNII: AVM951ZWST)
  • SODIUM OLEATE (UNII: 399SL044HN)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • KOJIC DIPALMITATE (UNII: 13N249RWTM)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM SULFATE (UNII: 0YPR65R21J)
  • BISULFITE ION (UNII: OJ9787WBLU)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

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.

Product Labeler Information

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

Labeler Name: Cosmetic Enterprises Ltd
Labeler Code: 56152
FDA Application Number: part358A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 01-10-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Divine Derrier Skin Bleaching Cream Product Label Images

Divine Derrier Skin Bleaching Cream 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

Otc - Active Ingredient

Active Ingredient PurposeHydroquinone 2% Skin lightener

Otc - Purpose

  • Uses Lightens skin discoloration sich as freckles, age and liver spots or pigment in the skin that may occur in pregnancy or from the use of oral contraceptions

Otc - Keep Out Of Reach Of Children

Keep out of childrenIf swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

  • Stop use and ask a doctor If rash occurs

Warnings

  • Warnings: for external use only
  • When using this product Avoid contact with eyesLimit sun exposure. Protect skin with a Broad-Spectrum sunscreen agent, wear protective clothing to cover bleached skin after treatment to prevent darkening from reoccuringSome users of this product may experience mild irritation. If skin irritation becomes severe, stop use and consult a physicianDo not use on children under 12 years of age unless directed by a physicianIf product consult with a doctor before useIf pregnant or breast-feeding Speak with a healthcare professional before useSunburn alertThis 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 afterwards

Dosage & Administration

DirectionsAdult apply a small amount

Inactive Ingredient

Inactive Ingredients Water(Aqua), Isopropyl Palmitate, Caprylic/capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, Propanediol, Glycolic Acid, Lactic Acid, Kojic Dipalmitate, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Niacinamide, Allantoin, Ferulic Acid, Butylene Glycol, hydrogenated Lecithin, Sodium Oleate, Oligopeptide-68, Dipotassium Glycrrhizate, Sodium Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Dimethicone, PEG-40 Stearate, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin, Phenoxyethanol, Frangrance.

* Please review the disclaimer below.

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