FDA.reportPublic FDA data

Pure Valley Miracle Age Spot

Manufacturer
Concept Laboratories, Inc.
Effective date
2017-10-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:48

Label at a glance#

ProductPure Valley Miracle Age Spot
Active ingredientHYDROQUINONE
Label structure11 sections

Indications and uses

for the gradual fading of dark (brownish) discolorations in the skin such as freckles age and liver spots pigment in the skin that may occur in pregnancy or from the use of oral contraceptives

Dosage and administration

Adults: apply a small amount as a thin layer on the affected area twice daily, or use 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 when used on very dark skin. for sensitive skin, test product on a small section of your skin inside your elbow

Storage and handling

For sensitive skin, test product on a small section of your skin inside your elbow. If no irritation develops after 24 hours proceed with application. Close product lid tightly after each use. Cream may darken when exposed to air. Product performance will not be affected. Do not use this product in combination with externally applied products containing resorcinol, phenol, salicylic acid or any type of acne produc...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 1.5%

Purpose

OTC - PURPOSE SECTION

Skin Lightener

Uses

INDICATIONS & USAGE SECTION

for the gradual fading of dark (brownish) discolorations in the skin such as

  • freckles
  • age and liver spots
  • pigment in the skin that may occur in pregnancy or from the use of oral contraceptives

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only.

  • avoid contact with eyes. If eye contact occurs flush thoroughly with water.

OTC - STOP USE SECTION

  • some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor

OTC - DO NOT USE SECTION

  • do not use on children under 12 years of age unless directed by a doctor

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • if pregnant or nursing, seek the advice of a health professional before using

OTC - WHEN USING SECTION

When using this product do not use on cracked, irritated or inflamed skin

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults: apply a small amount as a thin layer on the affected area twice daily, or use 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 when used on very dark skin.
  • for sensitive skin, test product on a small section of your skin inside your elbow

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glyceryl Stearate SE, Cetearyl Alcohol, Mineral Oil, Ceteareth-20, Isopropyl Myristate, Glycerin, Petrolatum, Butyrospermum Parkii (Shea Butter), Sodium Metabisulfite, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben, Citric Acid, Glycolic Acid, Ascorbic Acid, Glycyrrhiza Glabra (Licorice) Root Extract, Disodium EDTA, Fragrance.

Other Information

STORAGE AND HANDLING SECTION

  • For sensitive skin, test product on a small section of your skin inside your elbow. If no irritation develops after 24 hours proceed with application.
  • Close product lid tightly after each use. Cream may darken when exposed to air. Product performance will not be affected.
  • Do not use this product in combination with externally applied products containing resorcinol, phenol, salicylic acid or any type of acne product unless directed by a doctor.
  • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

SPL UNCLASSIFIED SECTION

Manufactured by Concept Laboratories, Inc., Chicago, IL 60642 (USA)

PRINCIPAL DISPLAY PANEL - 113 g Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PURE VALLEY®

Miracle–Age Spot

FADE CREME

Skin Lightening

with Alpha Hydroxy Acids & Shea Butter

4oz. (113g)e

PRINCIPAL DISPLAY PANEL - 113 g Jar Label
PRINCIPAL DISPLAY PANEL - 113 g Jar Label

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64058-116-342020-01-31C16284748780-19d75b9d0-8cf5-f424-e053-dadaa90a57cePure Valley ® Miracle Age Spot

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64058-116-34Pure Valley Miracle Age Spot113 g in 1 JARLOTION1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64058-116PURE VALLEY MIRACLE AGE SPOT (HYDROQUINONE) LOTION [CONCEPT LABORATORIES, INC.]1Legacy NDC, 1 package rows20171029_660a248b-fe77-4966-8c5c-c22cc0f5d240.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64058-11664058-116-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROQUINONEXV74C1N1AEACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
SHEA BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
Water059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCOLIC ACID0WT12SX38SIACT
DMDM HYDANTOINBYR0546TOWIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
SODIUM METABISULFITE4VON5FNS3CIACT

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
385b3cdc-56c0-4cea-982e-609a9c0049ce660a248b-fe77-4966-8c5c-c22cc0f5d2402017-10-27WarningsExact identifier
spl id: 385b3cdc-56c0-4cea-982e-609a9c0049ce
spl set id: 660a248b-fe77-4966-8c5c-c22cc0f5d240

Reported adverse events (FAERS/openFDA)#

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