Ultra Glow Fade Cream (2% Hydroquinone and 1.5% Padimate O)

Manufacturer
Keystone Laboratories
Effective date
2018-01-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:57

Label at a glance#

ProductUltra Glow Fade
Active ingredientHYDROQUINONE, PADIMATE O
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

2% Hydroquinone ..... Skin Lightener

1.5% Padimate O.......Subscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Skin lightener

INDICATIONS & USAGE SECTION

Skin Lightener

Sunscreen

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

www.keystone-labs.com

1-800-772-8860  / Memphis, TN 38101-2026

MADE IN U.S.A.

PM-LB 0011

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

water, stearyl stearate, propylene glycol, cetyl alcohol, isopropyl myristate, mineral oil, sodium metabisulfite, fragrance, steareth 20, methylparaben, butylhydoxytoluene, prophyl gallate, sodium sulfite, sodium sulfite, tetrasodium EDTA, propylparaben, citric acid, aloe barbadensis (Leaf Juice)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROQUINONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58318-008-012020-01-31C16284748780-19d75b9cf-ebe8-f424-e053-dadaa90a57ceUltra Glow Fade Cream (2% Hydroquinone and 1.5% Padimate O)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58318-008-01Ultra Glow Fade102 g in 1 JARCREAM1021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58318-008ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]1Legacy NDC, 1 package rows20180104_61f59bc5-2f46-764a-e053-2991aa0acb19.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58318-00858318-008-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
61f59bc5-2f47-764a-e053-2991aa0acb1961f59bc5-2f46-764a-e053-2991aa0acb192018-01-03WarningsExact identifier
spl id: 61f59bc5-2f47-764a-e053-2991aa0acb19
spl set id: 61f59bc5-2f46-764a-e053-2991aa0acb19

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.