Label: PURE VALLEY MIRACLE AGE SPOT- hydroquinone lotion

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated October 27, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydroquinone 1.5%

  • Purpose

    Skin Lightener

  • 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
  • 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

    • 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

    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

    • 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.
  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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)