PURE VALLEY MIRACLE AGE SPOT (HYDROQUINONE) LOTION [CONCEPT LABORATORIES, INC.]

PURE VALLEY MIRACLE AGE SPOT (HYDROQUINONE) LOTION [CONCEPT LABORATORIES, INC.]
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NDC 64058-116-34
Set ID 660a248b-fe77-4966-8c5c-c22cc0f5d240
Category HUMAN OTC DRUG LABEL
Packager Concept Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART358A
  • 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)

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