Label: I-MAX LIGHTENING 5- hydroquinone cream

  • 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 9, 2018

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:
    HYDROQUINONE USP 2%

  • PURPOSE

    PURPOSE:

    SKIN LIGHTENING

  • INDICATIONS & USAGE

    USES:

    FOR THE GRADUAL FADING OF DARK AREAS OF THE SKIN.

  • WARNINGS

    WARNINGS:

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

  • STOP USE

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

  • 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.

  • PEDIATRIC USE

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

  • 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.

  • 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.

  • QUESTIONS

    QUESTIONS? 1-323-733-7033

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    5_Lightening_LBL

  • INGREDIENTS AND APPEARANCE
    I-MAX LIGHTENING 5 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42952-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42952-201-1259 g in 1 TUBE; Type 0: Not a Combination Product09/18/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A09/18/2012
    Labeler - MAXLIFE USA, INC. (785111431)