Label: LIGHT THE WAY- hydroquinone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 May 2, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT         HYDROQUINONE 2%

  • PURPOSE

    PURPOSE         SKIN LIGHTENING

  • INDICATIONS & USAGE

    USE  GRADUALLY AND EFFECTIVELY LIGHTENS DARK AREAS IN THE SKIN

  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    DO NOT USE

    • ON INFLAMED OR BROKEN SKIN.
    • FOR THE PREVENTION OF SUNBURN.
    • AS A SUNSCREEN.
  • ASK DOCTOR

    ASK A DOCTOR OR PHARMACIST BEFORE USE IF

    • PREGNANT OR LACTATING.
    • IN COMBINATION WITH PRODUCTS CONTAINING RESORCINOL, PHENOL, OR SALICYLIC ACID.
    • BY CHILDREN UNDER THE AGE OF 12.
  • STOP USE

    STOP USE AND ASK A DOCTOR

    • IF AREAS DARKEN OR BLUE-BLACK DARKENING OCCURS.
    • MILD IRRITATION MAY OCCUR. IF IRRITATION BECOMES SEVERE, STOP USE AND CONSULT A DOCTOR.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN * IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • ADULTS ONLY
    • PM: APPLY SIDE 1 HYDROQUINONE TO CLEAN SKIN. ALLOW TO DRY. NEXT APPLY SIDE 2 WITH RETINOL. ALLOW TO DRY. DAILY USE OF SUNSCREEN IS RECOMMENDED.
    • FOR BEST RESULTS: APPLY MYBODY'S PROTECT AND SERVE SUN SHIELD SPF 30 (AM ONLY) WHEN USING LIGHT THE WAY.
    • FOR SENSITIVE SKIN, TEST OVERNIGHT ON SMALL AREA (INSIDE ELBOW).
    • IF NO IMPROVEMENT IS SEEN AFTER 3 MONTHS, DISCONTINUE USE. ON VERY DARK SKIN, LIGHTENING EFFECT MAY NOT BE NOTICEABLE.
    • TO PREVENT DARKENING FROM REOCCURRING, USE A SUNSCREEN OR WEAR PROTECTIVE CLOTHING TO COVER TREATED SKIN DURING AND AFTER PRODUCT USE.
  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    * AVOID STORAGE AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS CHAMBER A: WATER,  HEXYL LAURATE, GLYCERYL STEARATE SE, CETYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, STEARIC ACID, BUTYROSPERMUM PARKII (SHEA BUTTER), GLYCERIN, CETETH-2, BEHENYL ALCOHOL, HYDROXYPROPYL STARCH PHOSPHATE, XANTHAN GUM, POTASSIUM HYDROXIDE, SODIUM SULFITE, FRAGRANCE, CAPRYLYL GLYCOL, PHENOXYETHANOL, CITRIC ACID, SODIUM METABISULFITE.

  • QUESTIONS

    QUESTIONS OR COMMENTS?

    CALL 877.423.1314 * WWW.LOVEMYBODY.COM

  • PRINCIPAL DISPLAY PANEL

    MYBODY

    LIGHT THE WAY

    BOOSTER PACK: HYPERPIGMENTATION

    MYBOOSTER * STEP 2

    light the way_INNER LBL

    LIGHT THE WAY_OUTER_BOX_Drug Facts Panel

    LIGHT THE WAY_OUTER_BOX_Front

  • WHEN USING

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES.
    • LIMIT SUN EXPOSURE.
  • INGREDIENTS AND APPEARANCE
    LIGHT THE WAY 
    hydroquinone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49520-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETETH-2 (UNII: 7H8VAM7778)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49520-201-511 in 1 BOX
    1NDC:49520-201-1115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A04/24/2012
    Labeler - mybody (004460532)
    Registrant - mybody (004460532)
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