NDC 0299-4608 Differin Dark Spot Correcting Serum

Hydroquinone 2%

NDC Product Code 0299-4608

NDC 0299-4608-01

Package Description: 1 BOTTLE, GLASS in 1 BOX > 30 mL in 1 BOTTLE, GLASS

NDC Product Information

Differin Dark Spot Correcting Serum with NDC 0299-4608 is a a human over the counter drug product labeled by Galderma Laboratories, L.p.. The generic name of Differin Dark Spot Correcting Serum is hydroquinone 2%. The product's dosage form is solution and is administered via topical form.

Labeler Name: Galderma Laboratories, L.p.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Differin Dark Spot Correcting Serum 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.

  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ALCOHOL (UNII: 3K9958V90M)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
  • HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SODIUM SULFITE (UNII: VTK01UQK3G)
  • WATER (UNII: 059QF0KO0R)

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: Galderma Laboratories, L.p.
Labeler Code: 0299
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: 05-07-2019 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.

Differin Dark Spot Correcting Serum 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 Ingredients

Hydroquinone 2%

Purpose

Skin Bleaching Agent

Uses

For the gradual fading of dark (brownish) discolorations in the skin such as freckles, age and liver spots.

Warnings

For external use only.When using this product■ Avoid contact with eyes.  ■ Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.Do not use■ on children under 12 years of age unless directed by a doctor.

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

■ Adults: 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 noticeable when used on very dark skin. ■ Children under12 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 reoccurring.

Inactive Ingredients

1,2-Hexanediol, Alcohol Denat., Caprylyl Glycol, Citric Acid, Disodium EDTA, Fragrance, Hippophae Rhamnoides Oil, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Polysorbate 20, Sodium Metabisulfite, Sodium Sulfite, Water

Otc - Questions

Distributed by:Galderma Laboratories, L.P.Fort Worth, TX 76177 USAAll trademarks are the property of their respective owners.Made in Canadawww.differin.com

Principle Display Panel

DIFFERIN®                  Dark SpotCorrecting Serum2% Hydroquinone Skin Lightener• Gradually fades dark brownish discoloration, pigment, spots and blotches  • Helps reduce the appearance of post acne marks • Improves luminosity1 FL OZ (30 mL)

* Please review the disclaimer below.

Previous Code
0299-4607
Next Code
0299-4805