NDC 62032-529 Nu-derm System Normal-dry Skin Transformation

Hydroquinone, Octisalate And Zinc Oxide

NDC Product Code 62032-529

NDC CODE: 62032-529

Proprietary Name: Nu-derm System Normal-dry Skin Transformation 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, Octisalate And Zinc Oxide 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.

NDC Code Structure

  • 62032 - Obagi Cosmeceutical Llc

NDC 62032-529-06

Package Description: 1 KIT in 1 CARTON * 57 g in 1 BOTTLE, PLASTIC (62032-100-36) * 198 mL in 1 BOTTLE, PLASTIC * 85 g in 1 TUBE (62032-141-10) * 57 g in 1 BOTTLE, PLASTIC (62032-101-36) * 48 g in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Nu-derm System Normal-dry Skin Transformation with NDC 62032-529 is a a human prescription drug product labeled by Obagi Cosmeceutical Llc. The generic name of Nu-derm System Normal-dry Skin Transformation is hydroquinone, octisalate and zinc oxide. The product's dosage form is kit and is administered via form.

Labeler Name: Obagi Cosmeceutical Llc

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription 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.

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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • WATER (UNII: 059QF0KO0R)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
  • TROLAMINE SALICYLATE (UNII: H8O4040BHD)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • WATER (UNII: 059QF0KO0R)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • C15-19 ALKANE (UNII: CI87N1IM01)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Labeler Information

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

Labeler Name: Obagi Cosmeceutical Llc
Labeler Code: 62032
Marketing Category: UNAPPROVED DRUG OTHER - 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: 12-02-2019 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.

Nu-derm System Normal-dry Skin Transformation 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

OBAGI NU-DERM®

Rx onlyFor external use only

Each gram of Obagi Nu-Derm® Clear contains:ACTIVE: Hydroquinone, USP 4% (40 mg/g)INACTIVES: ascorbic acid, BHT, butylparaben, cetyl alcohol, disodium EDTA, glycerin, lactic acid, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, tocopheryl acetate, water (aqua)

Each gram of Obagi Nu-Derm Blender® contains:ACTIVE: Hydroquinone, USP 4% (40 mg/g)INACTIVES: ascorbic acid, BHT, cetyl alcohol, disodium EDTA, glycerin, lactic acid, methylparaben, phenyl trimethicone, PPG-2 myristyl ether propionate, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, TEA-salicylate, tocopheryl acetate, water (aqua)

Each gram of Obagi Nu-Derm® Sunfader® contains:ACTIVES: Hydroquinone, USP 4% (40mg/g); Octinoxate, USP 7.5%; Oxybenzone, USP 5.5%INACTIVES: ascorbic acid, BHT, butylparaben, cetyl alcohol, disodium EDTA, glycerin, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, tocopheryl acetate, water (aqua)

Manufactured for:Obagi Cosmeceuticals LLC,Long Beach, CA 90806All products/brand names, whether designated by notice or not (®/TM), are trademarks of Obagi Cosmeceuticals LLC and/or its affiliates.©2019 Obagi Cosmeceuticals LLC.All rights reserved. www.obagi.comRevised 01/20199458404Obagi Nu-Derm® Clear (Hydroquinone, USP 4%) Skin Bleaching CreamObagi Nu-Derm Blender® (Hydroquinone, USP 4%) Skin Bleaching CreamObagi Nu-Derm Sunfader® (Hydroquinone, USP 4%; Octinoxate, USP 7.5%; Oxybenzone, USP 5.5%) Skin Bleaching Cream with Sunscreens

Sun Shield Matte Broad Spectrum SPF 50Net wt. 3 oz. (85 g) AM

Drug Facts

Distributed by Obagi Cosmeceuticals LLC,Long Beach, CA 90806

Description

Hydroquinone, USP 4% is 1, 4-benzenediol. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2; molecular weight is 110.11 g/mol. The chemical structure is in the diagram below.

Clinical Pharmacology

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas, which may be prevented by the use of sunscreen agents such as those contained in Obagi Nu-Derm Sunfader® and Obagi Nu-Derm® Sun Shield Matte Broad Spectrum SPF 50.

Indications And Usage

For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.

Contraindications

People with prior history of sensitivity or allergic reaction to this product or any of its ingredients should not use it. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Warnings

Hydroquinone is a skin-bleaching agent, which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product.Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check within 24 hours. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor. Close patient supervision is recommended.WARNINGS: Avoid contact with eyes, nose, mouth and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

For external use only

Precautions

(also see WARNINGS):Treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation, which does not preclude treatment.

Pregnancy Category C

Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated.

Nursing Mothers

It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.

Pediatric Usage

Safety and effectiveness in children below the age of 12 years have not been established.

Adverse Reactions

No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the product should be discontinued and the physician notified immediately.To report SUSPECTED ADVERSE REACTIONS, contact Obagi Cosmeceuticals LLC, at 1-800-636-7546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage And Administration

A thin application should be applied once or twice daily or as directed by a physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

How Supplied

Obagi Nu-Derm® Clear is available as follows:Net wt. 2 oz. (57 g) bottleNDC 62032-101-36Obagi Nu-Derm Blender® is available as follows:Net wt. 2 oz. (57 g) bottleNDC 62032-100-36Net wt. 1 oz. (28 g) bottleNDC 62032-100-10Obagi Nu-Derm Sunfader® is available as follows:Net wt. 2 oz. (57 g) bottleNDC 62032-116-36

Storage And Handling

Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight.1-800-636-7546

Otc - Purpose

Active ingredientsPurposeHomosalate 10%SunscreenOctisalate 5%SunscreenZinc Oxide 16.5%Sunscreen

Uses

  • Helps prevent sunburnIf used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

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 liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hoursSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:limit time in the sun, especially from 10 a.m.–2 p.m.wear long-sleeved shirts, pants, hats, and sunglasseschildren under 6 months: Ask a doctor

Other Information

  • Store at controlled room temperature: 15°C–25°C (59°F–77°F)protect this product from excessive heat and direct sun

Inactive Ingredients

Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone

* Please review the disclaimer below.