ULTRA-POTENT BRIGHTENING SERUM (HYDROQUINONE) GEL [VELOCITY PRODUCTION AND PACKAGING]

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ULTRA-POTENT BRIGHTENING SERUM (HYDROQUINONE) GEL [VELOCITY PRODUCTION AND PACKAGING]
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NDC 72591-4832-1
Set ID 777fceed-0028-5973-e053-2991aa0ac5e7
Category HUMAN OTC DRUG LABEL
Packager Velocity Production and Packaging
Generic Name
Product Class
Product Number
Application Number PART358A
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  • Active Ingredients

    ACTIVE INGREDIENT(S):

    Hydroquinone........... 2%

  • Purpose

    PURPOSE:

    Skin Lightener

  • Uses

    USES:

    For the gradual fading of hyperpigmentation spots

  • Warnings

    WARNINGS:

    When Using

    When uisng this product avoid contact with eyes. Some users of this product may experience a mild skin irritation.

    Stop Use

    Stop use and ask a doctor if skin irritation becomes severe.

    Keep out

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Sun Alert

    SUN ALERT:

    The Alpha and Beta Hydroxy Acids (AHA/BHA) in this product may increase sun sensitivity.

    Wear sunscreen or protective clothing during use to protect against sunburn and for a week afterwards. Continue sun protection after the lightening regimen to avoid UV-induced pigmentations.

  • Dosage & Administration

    Adults: apply a small amount as a thin layer on the affected area once or twice daily, or use as directed by a doctor. Do not use on or around the eye area.

  • Directions

    DIRECTIONS:

    • If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightning effect of this product may not be noticable when used on very dark skin.
    • Children under 12 years of age: do not use unless directed by a doctor.
    • Sun exposure should be limited by using a sunscreen agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccuring.
  • Inactive ingredients

    INACTIVE INGREDIENTS:

    Propylene Glycol, Alcohol Denat., Azelaic Acid, Aqua (Water), Hamamelis Virginiana (Witch Hazel) Water, Lactic Acid (L), Kojic Acid, Salicylic Acid, Alcohol, Ascorbic Acid (L), Hydroxypropyl Methylcellulose, Sodium Hydroxide

  • Questions or comments?

    Questions or comments?

    Admire My Skin, 340 Royal Poinciana Way #317-356, Palm Beach FL 33480

    www.admiremyskin.com

  • Principal display panel and carton images

    Principal display panel

    Container label

    First accordion label, beneath the principal display panel

    First accordion label

    Second accordion label, beneath the principal display panel

    Second accordion label

    Outer carton

    Box

  • INGREDIENTS AND APPEARANCE
    ULTRA-POTENT BRIGHTENING SERUM 
    hydroquinone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72591-4832
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.2 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    DISODIUM AZELATE (UNII: 0P4H8NH3UJ)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
    LACTIC ACID, L- (UNII: F9S9FFU82N)  
    KOJIC ACID (UNII: 6K23F1TT52)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    Coloryellow (Pale) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72591-4832-11 in 1 CARTON02/11/2019
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A10/26/2018
    Labeler - Velocity Production and Packaging (081076893)
    Registrant - CoValence (959735002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Velocity Production and Packaging081076893pack(72591-4832)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoValence Laboratories959735002manufacture(72591-4832)
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