Indications and uses
Glytone Skin Lightening Gel is indicated for the gradual lightening of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
GLYTONE Hydroquinone USP, 4% Skin Lightening Gel
- Manufacturer
- Genesis Pharmaceutical, Inc.
- Effective date
- 2016-08-10
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:24:43
Label at a glance#
ProductGlytone Clarifying
Active ingredientHYDROQUINONE
Label structure12 sections
Dosage and administration
Glytone Skin Lightening Gel should be applied daily at night to affected areas and rubbed in well, or as directed by a physician. If no lightening effect is seen after 2 months of treatment, use of this product should be discontinued. During the day, avoid sunlight exposure to treated areas by using an effective broad spectrum sunscreen (SPF 15 or higher) or by wearing sun-protective clothing.
Contacts and useful links#
Websitewww.glytone-usa.com
www.glytone-usa.com
www.glytone-usa.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Glytone
HYDROQUINONE USP, 4%
Skin Lightening Gel
Rx Only
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
I. DESCRIPTION
Each gram of Glytone Hydroquinone USP, 4% Skin Lightening Gel contains 40 mg of Hydroquinone USP in a gel base of Purified Water, Propylene Glycol, Carbomer 940, Sodium Bisulfite, Edetate Disodium, Sorbic Acid, and Glycerin. The chemical name for hydroquinone is: 1,4-benzenediol. The molecular formula is C6H6O2 and molecular weight is 110.11. Hydroquinone has the following structural formula:
II. 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 treated areas.
III. INDICATIONS AND USAGE
Glytone Skin Lightening Gel is indicated for the gradual lightening of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
IV. 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.
V. WARNINGS
SPL UNCLASSIFIED SECTION
A. Contains sodium bisulfite, a sulfite that may cause allergic-type reactions (e.g. hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons. 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.
SPL UNCLASSIFIED SECTION
B. May produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of treatment.
.
SPL UNCLASSIFIED SECTION
C. There are no sunscreen agents in Glytone Skin Lightening Gel. Since minimal sunlight exposure may reverse the lightening effect of this preparation, an effective broad spectrum sunscreen should be used during the day, and unnecessary sun exposure avoided, or sun-protective clothing should be worn to cover treated areas in order to prevent repigmentation from occurring.
For daytime lightening of unwanted hyperpigmented areas, Glytone SunVanish Skin Lightening Cream Broad Spectrum SPF 25 should be considered.
VI. PRECAUTIONS
See WARNINGS
SPL UNCLASSIFIED SECTION
A. Test for skin sensitivity before using Glytone Skin Lightening Gel 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.
Hydroquinone is a skin lightening 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.
B. Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with warm water and contact a physician.
C. Keep this and all medication out of the reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.
PREGNANCY SECTION
D. 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 not be used in pregnant women.
NURSING MOTHERS SECTION
E. Nursing mothers. It is not known whether topical hydroquinone is absorbed or excreted in human milk. This product is not recommended for use by nursing mothers.
PEDIATRIC USE SECTION
F. Pediatric usage. Safety and effectiveness in children below the age of 12 years have not been established. Do not use on children under 12 years of age.
VII. ADVERSE REACTIONS
No systemic adverse reactions to hydroquinone have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately.
Sensitivity to sodium bisulfite is a potential. See WARNINGS.
VIII. OVERDOSAGE
There have been no systemic reactions from the use of topical hydroquinone. However, 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, but indicates caution is warranted.
IX. DRUG DOSAGE AND ADMINISTRATION
Glytone Skin Lightening Gel should be applied daily at night to affected areas and rubbed in well, or as directed by a physician. If no lightening effect is seen after 2 months of treatment, use of this product should be discontinued.
During the day, avoid sunlight exposure to treated areas by using an effective broad spectrum sunscreen (SPF 15 or higher) or by wearing sun-protective clothing.
X. HOW SUPPLIED
Glytone Hydroquinone USP, 4% Skin Lightening Gel is available as follows:
| Size | NDC Number |
| NET WT. 2 OZ. / 56 g tube | 64760-202-02 |
Store at room temperature of 68-77° F (20-25° C). Do not expose to heat above 86° F (30° C) or direct sunlight.
Distributed by:
Genesis Pharmaceutical, Inc.
Parsippany, NJ 07054 U.S.A.
1-800-GLYTONE (459-8663)
Rev. 112015
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 64760-202-02
GLYTONE
Hydroquinone USP, 4%
Skin Lightening Gel
Rx Only
NET WT. 56 g / 2 OZ.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64760-202-02 | 2023-04-28 | C162847 | 48780-1 | 9d75b9d0-a58e-f424-e053-dadaa90a57ce | GLYTONE Hydroquinone USP, 4% Skin Lightening Gel |
| 64760-202-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a58e-f424-e053-dadaa90a57ce | GLYTONE Hydroquinone USP, 4% Skin Lightening Gel |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| HYDROQUINONE | ACTIVE INGREDIENT | XV74C1N1AE | 5 | |
| HYDROQUINONE | ACTIVE MOIETY | XV74C1N1AE | 5 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | 5 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 5 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 5 | |
| SODIUM BISULFITE | INACTIVE INGREDIENT | TZX5469Z6I | 5 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 |
Products#
Every source-derived product name is available through these pages.
- Glytone Clarifying
- Hydroquinone
- WATER
- PROPYLENE GLYCOL
- CARBOMER HOMOPOLYMER TYPE C
- SODIUM BISULFITE
- EDETATE DISODIUM
- SORBIC ACID
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 64760-202 | 64760-202-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROQUINONE | XV74C1N1AE | ACTIB |
| WATER | 059QF0KO0R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CARBOMER HOMOPOLYMER TYPE C | 4Q93RCW27E | IACT |
| SODIUM BISULFITE | TZX5469Z6I | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| SODIUM BISULFITE | SODIUM BISULFITE | TZX5469Z6I | DROPS / OPHTHALMIC | 0.06 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, EMULSION / INTRAVENOUS | 59 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / TOPICAL | 126 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| SODIUM BISULFITE | SODIUM BISULFITE | TZX5469Z6I | SOLUTION / IONTOPHORESIS | 0.06 %w/v | ||
| SODIUM BISULFITE | SODIUM BISULFITE | TZX5469Z6I | INJECTION, SUSPENSION / INTRA-ARTICULAR | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | CREAM, AUGMENTED / TOPICAL | 20 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO, SUSPENSION / TOPICAL | 1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION / OPHTHALMIC | 0.2 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO / TOPICAL | 1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRALESIONAL | 0.05 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SUSPENSION / ORAL | 40 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / TOPICAL | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, COATED / ORAL | 0.21 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / INTRAVENOUS | 50.33 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f99e950f-0f1e-0282-e053-6394a90a1746 | ad96d53f-431f-439f-9948-784f467b53dc | 2023-04-18 | Warnings, Adverse reactions | ad96d53f-431f-439f-9948-784f467b53dc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.