NDC 62032-500 Nu-derm Travel Set Normal/dry Skin Transformation System

Hydroquinone, Octinoxate And Zinc Oxide

NDC Product Code 62032-500

NDC CODE: 62032-500

Proprietary Name: Nu-derm Travel Set Normal/dry Skin Transformation System 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, Octinoxate 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 Cosmeceuticals Llc

NDC 62032-500-60

Package Description: 1 KIT in 1 CARTON * 30 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 28.5 g in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 28 g in 1 BOTTLE, PLASTIC

NDC Product Information

Nu-derm Travel Set Normal/dry Skin Transformation System with NDC 62032-500 is a a human prescription drug product labeled by Obagi Cosmeceuticals Llc. The generic name of Nu-derm Travel Set Normal/dry Skin Transformation System is hydroquinone, octinoxate and zinc oxide. The product's dosage form is kit and is administered via form.

Labeler Name: Obagi Cosmeceuticals 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)
  • 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 (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)
  • 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 (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)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • WATER (UNII: 059QF0KO0R)
  • ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • LAURETH-7 (UNII: Z95S6G8201)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Labeler Information

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

Labeler Name: Obagi Cosmeceuticals 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: 12-02-2004 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.

Nu-derm Travel Set Normal/dry Skin Transformation System Product Label Images

Nu-derm Travel Set Normal/dry Skin Transformation System 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

Rx OnlyFOR EXTERNAL USE ONLY

OMP, Inc.Long Beach, CA 90802USA1-800-636-7546Rev. 8/03

Description

Hydroquinone is 1,4-benzenediol. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6 H6 O2; molecular weight is 110.0.Each gram of Obagi Nu-Derm Blender contains Hydroquinone USP 40 mg/gm in a base of purified water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, saponins, disodium EDTA, BHT, and propylparaben.Each gram of Obagi Nu-Derm Clear contains Hydroquinone USP 40 mg/gm in a base of purified water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, lactic acid, saponins, disodium EDTA, methylparaben, BHT, propylparaben, and butylparaben.Each gram of Obagi Nu-Derm Sunfader contains Hydroquinone USP 40 mg/gm, Octinoxate USP, 7.5%, and Oxybenzone USP, 5.5%, in a base of purified water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, saponins, propylparaben, BHT, and butylparaben.

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 sunblocking agents or sunscreen agents contained in Obagi Nu-Derm Sunfader.

Indications And Usage

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Obagi Nu-Derm Sunfader is intended for daytime use as it contains sunscreen agents.

Contraindications

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

Caution

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 medication.Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and anesthetic effect may occur if applied to lips.Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Obagi Sunfader is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn.

Warning

Contains sodium metabisulfite, a sulfite that may cause serious allergic type reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attacks) in certain susceptible persons.

Precautions

(SEE WARNINGS)

General

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 medication should be discontinued and the physician notified immediately.

Dosage And Administration

A thin application should be applied to the affected area 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, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent repigmentation.

How Supplied

Obagi Nu-Derm Blender is available as follows:2 oz. (57 gm) bottleNDC 62032-100-361 oz. (28.5 gm) bottleNDC 62032-100-10Obagi Nu-Derm Clear is available as follows:2 oz. (57 gm) bottleNDC 62032-101-361 oz. (28.5 gm) bottleNDC 62032-101-10Obagi Nu-Derm Sunfader is available as:2 oz. (57 gm) bottleNDC 62032-116-36

Storage And Handling

Store at 25°C (77°F); excursion permitted to 15°C-30°C (59°F-86°F).

* Please review the disclaimer below.