Ultra Glow Fade
- Manufacturer
- Keystone Laboratories
- Effective date
- 2018-01-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 22:54:07
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
2% Hydroquinone ..... Skin Lightener
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
OTC - PURPOSE SECTION
Skin lightener
INDICATIONS & USAGE SECTION
Ultra Glow Fade Cream
2% Hydroquinone ...... Skin Lightener
WARNINGS SECTION
Warnings:
For external use only. Children under 12 years of age: Do not use unless directed by a doctor. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor. Avoid contact with eyes, rinse with water to remove. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin during and after treatment is completed in order to prevent darkening from reoccurring. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions:
Adults: Apply a small amount in a thin layer on the affected area twice daily or as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable on very dark skin.
OTHER SAFETY INFORMATION
Other Information: Protect the product in this container from excessive heat and direct sun. For expiration date, please see bottom of jar.
Distributed by
KEYSTONE LABORATORIES © 2013
1-800-772-8860 / Memphis, TN 38101-2026
MADE IN U.S.A.
PM-LB 0011
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
Aqua/Water/Eau, Stearyl Stearate, Glycerol Stearate, Propylene Glycol Alcohol, Isopropyl Myristate, Sodium Metabisulfite, Fragrance, Sodium Sulfite, Steareth 20, Methyl Paraben, Buthydroxytoluene, Propyl Gallate, Tetrasodium EDTA, Propyl Paraben, Citric Acid
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROQUINONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 85490a6b-2306-6bf2-c51b-eb63537dc2da | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58318-003-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-42d6-f424-e053-dadaa90a57ce | 2557b4dc-2e85-4611-afed-c299f4ed3bbf |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58318-003-01 | Ultra Glow Fade | 51 g in 1 CANISTER | CREAM | 51 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| HYDROQUINONE | ACTIVE INGREDIENT | XV74C1N1AE | 2 | |
| HYDROQUINONE | ACTIVE MOIETY | XV74C1N1AE | 2 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 2 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 2 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 2 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 2 | |
| METHYL ALCOHOL | INACTIVE INGREDIENT | Y4S76JWI15 | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| PROPYL GALLATE | INACTIVE INGREDIENT | 8D4SNN7V92 | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 | |
| SODIUM DITHIONATE | INACTIVE INGREDIENT | RPF7Z41GAW | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 2 | |
| SODIUM SULFITE | INACTIVE INGREDIENT | VTK01UQK3G | 2 | |
| STEARETH-20 | INACTIVE INGREDIENT | L0Q8IK9E08 | 2 | |
| STEARYL STEARATE | INACTIVE INGREDIENT | 5WX2EGD0DK | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Ultra Glow Fade
- Hydroquinone
- WATER
- GLYCERYL MONOSTEARATE
- SODIUM LAURYL SULFATE
- PROPYLENE GLYCOL
- ISOPROPYL MYRISTATE
- CETYL ALCOHOL
- SODIUM METABISULFITE
- BISULFITE ION
- STEARYL STEARATE
- STEARETH-20
- METHYLPARABEN
- PROPYLPARABEN
- BUTYLATED HYDROXYTOLUENE
- PROPYL GALLATE
- SODIUM SULFITE
- EDETATE DISODIUM
- CITRIC ACID MONOHYDRATE
- METHYL ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58318-003 | 58318-003-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / OPHTHALMIC | 0.03 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | POWDER, FOR SUSPENSION / ORAL | 64 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TOPICAL | 29 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | OINTMENT / TOPICAL | 14 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION / INTRAVENOUS | NA | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SPRAY / TOPICAL | 3665 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE, DENTIFRICE / DENTAL | 1.4 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | DROPS / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, EFFERVESCENT / ORAL | 1.5 mg | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | TABLET / ORAL | 7 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / TOPICAL | 17 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION / TOPICAL | 3 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOAP / TOPICAL | 0.02 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RECTAL | 0.02 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SOFT TISSUE | 0.05 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| SODIUM SULFITE | SODIUM SULFITE | VTK01UQK3G | INJECTION / SUBCUTANEOUS | 0.15 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, CHEWABLE / ORAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w | ||
| SODIUM SULFITE | SODIUM SULFITE | VTK01UQK3G | INJECTION / INTRAVENOUS | 96 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / NASAL | 140 mg | ||
| SODIUM SULFITE | SODIUM SULFITE | VTK01UQK3G | CREAM / TOPICAL | 8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SUSPENSION / ORAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SUPPOSITORY / VAGINAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO, SUSPENSION / TOPICAL | 1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAMUSCULAR | 10 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 6 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / SUBLINGUAL | 1.1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM, EXTENDED RELEASE / TRANSDERMAL | 20.4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / ORAL | 269 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SOFT TISSUE | 0.02 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION, EXTENDED RELEASE / ORAL | 140.8 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / VAGINAL | 50 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 |
|---|---|---|---|---|---|---|
| 626f5f92-05e4-5924-e053-2a91aa0ac58c | 2557b4dc-2e85-4611-afed-c299f4ed3bbf | 2018-01-10 | Warnings | 626f5f92-05e4-5924-e053-2a91aa0ac58c 2557b4dc-2e85-4611-afed-c299f4ed3bbf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
