NDC 71177-008 Bright Malika And Khadija Brightening Spot Treatment

Hydroquinone

NDC Product Code 71177-008

NDC Code: 71177-008

Proprietary Name: Bright Malika And Khadija Brightening Spot Treatment Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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
  • 71177 - Pulsaderm, Llc
    • 71177-008 - Bright Malika And Khadija Brightening Spot Treatment

NDC 71177-008-15

Package Description: 1 TUBE in 1 BOX > 15 mL in 1 TUBE

NDC Product Information

Bright Malika And Khadija Brightening Spot Treatment with NDC 71177-008 is a a human over the counter drug product labeled by Pulsaderm, Llc. The generic name of Bright Malika And Khadija Brightening Spot Treatment is hydroquinone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Pulsaderm, Llc

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 Additional informationCallout TooltipWhat 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.


Bright Malika And Khadija Brightening Spot Treatment Active Ingredient(s)

Additional informationCallout TooltipWhat 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 20 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • KOJIC ACID (UNII: 6K23F1TT52)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • WHITE MULBERRY (UNII: MN25R0HH5A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • UREA (UNII: 8W8T17847W)
  • GRAPE (UNII: 6X543N684K)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pulsaderm, Llc
Labeler Code: 71177
FDA Application Number: part358A Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Bright Malika And Khadija Brightening Spot Treatment Product Label Images

Bright Malika And Khadija Brightening Spot Treatment 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

Active Ingredient:

Hydroquinone 2.00%

Uses:

Lightens dark spots in the skin such as freckles, age spots and liver spots.

Warnings:

*For external use only.


*Avoid contact with eyes or eyelids.


*Some users of this product may experience mild skin irritation. Consult physician if skin irritation becomes severe.

Do Not Use On

Children under 12, unless directed by physician.

Keep Out Of Reach Of Children.

If swallowed, contact physician or poison control center immediately.

Directions:

  • Adults: Apply a thin layer on the affected areas twice daily, or as directed by physician.If no improvement is seen after three months of treatment, discontinue use of this product and consults physician.Lightening effect of this product may be less noticeable on very dark skin.Children under 12-years of age: Do not use this product unless directed by physician Sun exposure should be limited by using sunscreen agent, sun blocking agent, or protective clothing to cover bleached skin when using, and after using this product, in order to prevent darkening from reoccurring.

Other Ingredients:

Algae Extract, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Bis-Vinyl Dimethicone/Dimethicone Copolymer, Butylene Glycol, C12-15 Alkyls Benzoate, Caprylic/Capric Triglyceride, 


Cyclopentasiloxane, Diazolidinyl Urea, Glucosamine HCI, Glycerin, Glycolic Acid, Glycyrrhiza Glabra (Licorice) Extract,


Hydroxyethylcellulose, lsohexadecane, Kojic Acid, Methyl Paraben, Morus Alba (Mulberry) Extract, Polysorbate 80, Propyl Paraben,


Propylene Glycol, Sodium Acryloyldimethyl Taurate Copolymer, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Metabisulfite,


Sodium PCA, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Urea, Vitis Vinifera (Grape) Seed Extract, Yeast Extract.

* Please review the disclaimer below.

Previous Code
71177-005
Next Code
71178-775