Overview
Hydroquinone is a topical lightening product found in OTC products, and is used to correct skin discoloration associated with disorders of hyperpigmentation including melasma, post-inflammatory hyperpigmention, sunspots, and freckles. It can be used alone, but is more frequently found in combination with other agents such as alpha-hydroxy acids, corticosteroids, retinoids, or sunscreen. Hydroquinone has come under scrutiny due to several complications associated with its use, including dermal irritation, exogenous onchronosis, and carginogenicity. As a result of these concerns, hydroquinone has been banned in the EU and UK.
Indication
Hydroquinone is used as an OTC topical lightening agent for disorders of hyperpigmentation including melasma, post-inflammatory hyperpigmention, sunspots and freckles.
Associated Conditions
- Acne Vulgaris
- Melasma
- Skin hyperpigmentation
- Moderate Melasma
- Severe Melasma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/05 | Phase 2 | Completed | National Skin Centre | ||
2022/08/23 | Phase 2 | Completed | |||
2021/08/19 | Not Applicable | Completed | Unilever R&D | ||
2021/05/06 | Phase 4 | Active, not recruiting | |||
2020/10/22 | Not Applicable | UNKNOWN | |||
2019/06/12 | Phase 2 | Completed | Islamabad Medical and Dental College | ||
2018/11/23 | Phase 3 | Completed | |||
2018/07/12 | Phase 3 | UNKNOWN | Centro Dermatológico Dr. Ladislao de la Pascua | ||
2017/02/09 | Phase 2 | Completed | Mae Fah Luang University Hospital | ||
2014/05/14 | Phase 4 | Completed | Sadick Research Group |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Nivagen Pharmaceuticals, Inc. | 75834-137 | TOPICAL | 40 mg in 1 g | 2/7/2024 | |
| DR. THROWER'S SKINCARE, INC. | 69299-301 | TOPICAL | 12 g in 100 g | 5/22/2015 | |
| Dermavance Pharmaceuticals | 30815-0040 | TOPICAL | 40 mg in 1 g | 1/12/2023 | |
| Sincerus Florida, LLC | 72934-6115 | TOPICAL | 4 g in 100 g | 5/20/2019 | |
| O Skin Care LLC | 71421-801 | TOPICAL | 0.02 g in 1 g | 6/5/2022 | |
| O Skin Pharmaceutical Corporation | 72864-563 | TOPICAL | 0.06 g in 1 g | 3/22/2021 | |
| Sincerus Florida, LLC | 72934-6067 | TOPICAL | 6 g in 100 g | 5/20/2019 | |
| ZO Skin Health, Inc. | 42851-035 | TOPICAL | 0.04 mg in 1 mL | 4/21/2022 | |
| Galderma Laboratories, L.P. | 0299-5950 | TOPICAL | 40 mg in 1 g | 2/15/2023 | |
| Sincerus Florida, LLC | 72934-6230 | TOPICAL | 6 g in 100 g | 7/2/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Obagi Nu-Derm Clear | SIN13518P | CREAM | 4% | 8/13/2008 | |
| Obagi Nu-Derm Blender | SIN13519P | CREAM | 4% | 8/13/2008 | |
| TRI-LUMA CREAM | SIN12607P | CREAM | 40 mg/g | 10/19/2004 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| JOHN PLUNKETT'S SUPERFADE SKIN CREAM tube | 341504 | Medicine | A | 8/13/2020 | |
| GRANGE ACTIVE SKIN LIGHTENING CREAM | 91036 | Lady Alexander Pty Ltd | Medicine | A | 9/17/2002 |
| JOHN PLUNKETT’S SUPERFADE FACE TREATMENT CREAM tube | 11629 | Medicine | A | 9/12/1991 | |
| Superfade Original Cream | 206618 | Medicine | A | 3/4/2013 | |
| Superfade Cream | 197217 | Medicine | A | 5/4/2012 | |
| JOHN PLUNKETT'S SUPERFADE TREATMENT CREAM tube | 52376 | Medicine | A | 5/25/1995 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| RODAN & FIELDS PROACTIV SOLUTION: SKIN LIGHTENING LOTION | guthy-renker llc | 02250543 | Lotion - Topical | 2 % | 3/28/2004 |
| PORCELANA MEDICATED FADE CREAM - ORIG. FMLA | lavoris-dep corporation | 02053764 | Cream - Topical | 2 % | 12/31/1995 |
| ACTIVE 4 | vivier canada incorporated | 02248851 | Cream - Topical | 4 % | 9/6/2005 |
| ZARINA SKIN LIGHTENING CREAM WITH SUNSCREENING FILTER | fairtrade international co. ltd. | 02266490 | Cream - Topical | 2 % | N/A |
| ESOTERICA SCENTED-FORTIFIED WITH SUNSCREEN | 02029944 | Cream - Topical | 2 % | 12/31/1960 | |
| DRULA FADE CREAM SUPERFORTE MEDICATED | drula-fabrik, dr. o. druckery gmbh | 02010593 | Cream - Topical | 4 G / 100 G | 12/31/1994 |
| OBAGI PROTOCOLS CLEAR | obagi medical products a div of valeant pharmaceuticals north america llc | 02244870 | Cream - Topical | 2 % | 5/31/2002 |
| ULTRA GLOW SKIN TONE CREAM FOR OILY SKIN | keystone laboratories inc. | 02188015 | Cream - Topical | 2 % | 12/31/1995 |
| SOLAQUIN FORTE | valeant canada lp / valeant canada s.e.c. | 01977830 | Cream - Topical | 4 % | 12/31/1992 |
| PALMER'S SKIN SUCCESS FADE CREAM-FOR DRY SKN | e.t. browne drug co., inc. | 02046075 | Cream - Topical | 2 % | 9/30/1994 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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