PURE VALLEY MIRACLE AGE SPOT- hydroquinone lotion 
Concept Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pure Valley® Miracle Age Spot

Drug Facts

Active ingredient

Hydroquinone 1.5%

Purpose

Skin Lightener

Uses

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

Warnings

For external use only.

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

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

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

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

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

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control Center right away

Directions

Inactive ingredients

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

Questions or comments?

Call 1-888-373-8831 or visit www.conceptlabs.org

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

PRINCIPAL DISPLAY PANEL - 113 g Jar Label

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
PURE VALLEY MIRACLE AGE SPOT 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
SHEA BUTTER (UNII: K49155WL9Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-116-34113 g in 1 JAR; Type 0: Not a Combination Product10/01/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart358A10/01/2002
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-116)

Revised: 10/2017
Document Id: 385b3cdc-56c0-4cea-982e-609a9c0049ce
Set id: 660a248b-fe77-4966-8c5c-c22cc0f5d240
Version: 1
Effective Time: 20171027
 
Concept Laboratories, Inc.