I-MAX LIGHTENING 5 (HYDROQUINONE) CREAM [MAXLIFE USA, INC.]

I-MAX LIGHTENING 5 (HYDROQUINONE) CREAM [MAXLIFE USA, INC.]
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NDC 42952-201-12
Set ID e874f160-1f05-4f53-8e41-8d41c2b441d8
Category HUMAN OTC DRUG LABEL
Packager MAXLIFE USA, INC.
Generic Name
Product Class
Product Number
Application Number PART358A
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:
    HYDROQUINONE USP 2%

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  • PURPOSE

    PURPOSE:

    SKIN LIGHTENING

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  • INDICATIONS & USAGE

    USES:

    FOR THE GRADUAL FADING OF DARK AREAS OF THE SKIN.

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  • WARNINGS

    WARNINGS:

    AVOID CONTACT WITH EYES. SOME USERS MAY EXPERIENCE MILD SKIN IRRITATION.

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  • STOP USE

    IF IRRITATION BECOMES SEVERE, STOP USE AND CONSULT A DOCTOR.

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  • OTHER SAFETY INFORMATION

    THIS PRODUCT IS NOT INTENDED FOR USE IN THE PREVENTION OF SUNBURN AND CONTAINS AN ALPHA HYDROXY ACID (AHA) THAT MAY INCREASE YOUR SKIN'S SENSITIVITY TO THE SUN AND PARTICULARLY THE POSSIBILITY OF SUNBURN. SUN EXPOSURE SHOULD BE LIMITED BY USING A SUNSCREEN AGENT OR PROTECTIVE CLOTHING TO COVER BLEACHED SKIN AFTER TREATMENT IS COMPLETED TO PREVENT DARKENING FROM REOCCURING.

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  • PEDIATRIC USE

    DO NOT USE ON CHILDREN UNDER 12 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.

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  • DOSAGE & ADMINISTRATION

    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.

    CHILDREN UNDER 12 YEARS OF AGE: DO NOT USE UNLESS DIRECTED BY A DOCTOR.

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    C13-14 ISOPARAFFIN, CETYL ALCOHOL, ETHYLHEXYLGLYCERIN, ETHYLHEXYL STEARATE, GLYCERIN, GLYCERYL STEARATE, GLYCOLIC ACID, ISOPROPYL MYRISTATE, LAURETH-7, NIACINAMIDE, PANTOTHENIC ACID, PEG-100 STEARATE, PHENOXYETHANOL, POLYACRYLAMIDE, PYRIDOXINE HCL, SODIUM HYDROXIDE, SODIUM METABISULFITE, TETRAHEXYLDECYL ASCORBATE, WATER (AQUA), XANTHAN GUM.

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  • QUESTIONS

    QUESTIONS? 1-323-733-7033

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

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  • INGREDIENTS AND APPEARANCE
    I-MAX LIGHTENING 5 
    hydroquinone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42952-201
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-7 (UNII: Z95S6G8201)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTOTHENIC ACID (UNII: 19F5HK2737)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42952-201-12 59 g in 1 TUBE; Type 0: Not a Combination Product 09/18/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part358A 09/18/2012
    Labeler - MAXLIFE USA, INC. (785111431)
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