nu-derm system normal-dry skin transformation
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- nu-derm system normal-dry skin transformation
- Generic name
- HYDROQUINONE, OCTISALATE AND ZINC OXIDE
- Manufacturer
- OBAGI COSMECEUTICAL LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 7548658a-5371-4aed-baf8-e5dc54262223
- SPL ID
- ed79404d-956a-4f71-b348-3e89930fac3d
- Version
- 3
- Effective date
- 2025-03-14
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:27:46
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| brand name | nu-derm system normal-dry skin transformation | openfda.brand_name | |
| generic name | HYDROQUINONE, OCTISALATE AND ZINC OXIDE | openfda.generic_name | |
| manufacturer name | OBAGI COSMECEUTICAL LLC | openfda.manufacturer_name | |
| ndc | package | 62032-141-10 | openfda.package_ndc |
| ndc | package | 62032-100-36 | openfda.package_ndc |
| ndc | package | 62032-101-36 | openfda.package_ndc |
| ndc | package | 62032-529-06 | openfda.package_ndc |
| ndc | product | 62032-529 | openfda.product_ndc |
| ndc11 | package | 62032010136 | derived:openfda.package_ndc |
| ndc11 | package | 62032010036 | derived:openfda.package_ndc |
| ndc11 | package | 62032052906 | derived:openfda.package_ndc |
| ndc11 | package | 62032014110 | derived:openfda.package_ndc |
| rxcui | 197795 | openfda.rxcui | |
| spl id | ed79404d-956a-4f71-b348-3e89930fac3d | id | |
| spl set id | 7548658a-5371-4aed-baf8-e5dc54262223 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.
warnings
Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.