NDC 63742-025 Dr. Lightening Ultra-potent Facial

Hydroquinone

NDC Product Code 63742-025

NDC CODE: 63742-025

Proprietary Name: Dr. Lightening Ultra-potent Facial 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

  • 63742 - Clinical Resolution Laboratory, Inc.
    • 63742-025 - Dr. Lightening Ultra-potent Facial

NDC 63742-025-01

Package Description: 44 g in 1 TUBE

NDC Product Information

Dr. Lightening Ultra-potent Facial with NDC 63742-025 is a a human over the counter drug product labeled by Clinical Resolution Laboratory, Inc.. The generic name of Dr. Lightening Ultra-potent Facial is hydroquinone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Clinical Resolution Laboratory, Inc.

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.

Dr. Lightening Ultra-potent Facial 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 20 mg/g

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.

  • ARBUTIN (UNII: C5INA23HXF)
  • ARGININE (UNII: 94ZLA3W45F)
  • AZELAIC ACID (UNII: F2VW3D43YT)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
  • ISODODECANE (UNII: A8289P68Y2)
  • KOJIC ACID (UNII: 6K23F1TT52)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM SULFITE (UNII: VTK01UQK3G)
  • TRIDECETH-6 (UNII: 3T5PCR2H0C)

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: Clinical Resolution Laboratory, Inc.
Labeler Code: 63742
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: 02-15-2019 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: 12-31-2021 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 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.

Dr. Lightening Ultra-potent Facial Product Label Images

Dr. Lightening Ultra-potent Facial 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%

Purpose

Skin Lightener

Uses:

For the gradual fading of hyperpigmentation spots.

Warnings:

For external use only

When Using This Product

  • Avoid contact with eyes.some users of this product may experience mild irritation. If skin irritation becomes severe, stop use and consult a doctor.for external use only.

For External Use Only.

  • If skin irritation becomes severe.

If Pregnant Or Breastfeeding,

  • Consult a doctor before use.

Do Not Use This Product If

Children under 12 years of age, unless directed by a doctor

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.Sunburn AlertThe Alpha and Beta Hydroxy Acids (AHA/BHA)in this product may increase sun sensitivity. Wear sunscreen or protective clothing during use to protect against sunburn and for a week afterwards. Continue sun protection after the lightening regimen to avoid UV-induced pigmentations.

Directions

  • Adults: apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor.Do not use on or around the eye area.If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may be noticeable when used on very dark skin.Sun exposure should be limited by using a sunscreen agent, a 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 Information

Store at 20°-25° C (68-77° F)

Inactive Ingredients

Arbutin, Arginine, Azelaic Acid, Carrageenan, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Cyclopentasiloxane, Dimethyl Isosorbide, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Hydrogenated Polydecene, Isododecane, Kojic Acid, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Purified Water, Salicylic Acid, Sodium Benzoate, Sodium  Polyacrylate, Sodium Sulfite, Trideceth-6

* Please review the disclaimer below.