DUAL ACTION SKIN LIGHTENER (HYDROQUINONE) LOTION [NEOTERIC COSMETICS, INC.]

DUAL ACTION SKIN LIGHTENER (HYDROQUINONE) LOTION [NEOTERIC COSMETICS, INC.]
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NDC 62673-162-21
Set ID 0aa9ee02-abc7-450b-b377-f264aebb3cf8
Category HUMAN OTC DRUG LABEL
Packager Neoteric Cosmetics, Inc.
Generic Name
Product Class
Product Number
Application Number PART358A
  • SPL UNCLASSIFIED SECTION

    Dual Action Skin Lightener

    Drug Facts

  • Active Ingredients

    Hydroquinone 2%

  • Purpose

    Skin Lightener

  • Uses

    • Lightens dark spots in the skin, such as freckles, age spots, and liver spots.

  • Warnings

    • Avoid contact with eyelids and eyes

    • 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.

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • Adults: apply a thin layer on the affected areas twice daily, or 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

    • Children under 12 years of age: do not use this product unless directed by a doctor. Sun exposure should be limited by using a sunscreen agent, sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

    Sunburn Alert

    • This product contains an Alpha Hydroxy Acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

  • Inactive Ingredients

    Water, Glycolic Acid, Propylene Glycol, Isopropyl Palmitate, Mineral Oil, Glyceryl Stearate, Cetyl Alcohol, Ozokerite, Sodium Hydroxide, Steareth-20, Laureth-23, Tocopherol (Vitamin E), Dimethicone, Xanthan Gum, Sodium PVM/MA Decadiene Crosspolymer, Sorbic Acid, Sodium Metabisulfite, Imidazolidinyl Urea, Tetrasodium EDTA, Fragrance, BHT

    MANUFACTURED FOR NEOTERIC COSMETICS, INC., Greenwood Village, CO 80111

  • PRINCIPAL DISPLAY PANEL

    Alpha
    skin care
    Dual Action
    Skin Lightener
    Net Wt. 0.85 oz. (24g)

    Alpha
skin care
Dual Action
Skin Lightener
Net Wt. 0.85 oz. (24g)

  • INGREDIENTS AND APPEARANCE
    DUAL ACTION SKIN LIGHTENER 
    hydroquinone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62673-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE.02 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CERESIN (UNII: Q1LS2UJO3A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    LAURETH-23 (UNII: N72LMW566G)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBIC ACID (UNII: X045WJ989B)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    IMIDUREA (UNII: M629807ATL)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62673-162-211 in 1 CARTON05/01/2006
    124 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart358A05/01/2006
    Labeler - Neoteric Cosmetics, Inc. (790615181)

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