NDC 70605-007 Meaningful Beauty Dark Spot Correcting Treatment

Hydroquinone

NDC Product Code 70605-007

NDC CODE: 70605-007

Proprietary Name: Meaningful Beauty Dark Spot Correcting Treatment 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

  • 70605 - Guthy-renker Llc
    • 70605-007 - Meaningful Beauty Dark Spot Correcting Treatment

NDC 70605-007-29

Package Description: 1 TUBE in 1 BOX > 2 mL in 1 TUBE

NDC Product Information

Meaningful Beauty Dark Spot Correcting Treatment with NDC 70605-007 is a a human over the counter drug product labeled by Guthy-renker Llc. The generic name of Meaningful Beauty Dark Spot Correcting Treatment is hydroquinone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Guthy-renker Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Meaningful Beauty Dark Spot Correcting Treatment 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)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
  • PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • SODIUM SULFITE (UNII: VTK01UQK3G)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Guthy-renker Llc
Labeler Code: 70605
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: 04-30-2016 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.

Meaningful Beauty Dark Spot Correcting Treatment Product Label Images

Meaningful Beauty Dark Spot Correcting 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

Other

Drug Facts

Distributed by:Meaningful Beauty®Santa Monica, CA 90405

Active Ingredient

Hydroquinone 2%

Purpose

Skin Lightener

Use

Lightens discoloration spots and blotches in the skin such as age and liver spots

Warnings

For external use only

Otc - When Using

  • Avoid contact with the eyes, lips, and mouth.

Otc - Do Not Use

  • Do not use on children under 12 years of age unless directed by a doctor.

Otc - Stop Use

Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

Otc - Ask Doctor/Pharmacist

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued.Lightening effect of this product may not be noticed on very dark skin.Children under 12 years of age: Do not use unless directed by a doctor.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 recurring.

Inactive Ingredients

Water, octyldodecanol, cyclopentasiloxane, hexylene glycol, polyquaternium-37, glycolic acid, cyclohexasiloxane, cetearyl alcohol, propylene glycol dicaprylate/dicaprate, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, propylene glycol, glyceryl dilaurate, PPG-1 trideceth-6, glyceryl stearate, PEG-100 stearate, PEG-40 stearate, sodium sulfite, sodium metabisulfite, sodium hydroxide, disodium EDTA, diazolidinyl urea, methylparaben, propylparaben, fragrance

* Please review the disclaimer below.