Label: DR. LIN SKINCARE ACNE- benzoyl peroxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 28, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    BENZOYL PEROXIDE 2.5%

  • PURPOSE

    PURPOSE

    ACNE TREATMENT

  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    DO NOT USE THIS MEDICATION IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE.

  • ASK DOCTOR/PHARMACIST

    ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPCAL ACNE MEDICATONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASETHE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONEMEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

  • WHEN USING

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WTH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.
    • KEEP AWAY FROM LIPS AND MOUTH.
    • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
  • STOP USE

    STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

  • 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.

  • INDICATIONS & USAGE

    USE FOR THE TREATMENT OF ACNE

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • USE TWICE DAILY AM AND PM.
    • AFTER CLEANSING, APPLY TO ENTIRE FACE AVOIDING THE EYE AREA.
    • DO NOT RINSE.
    • ALLOW TO DRY.
    • IF GOING OUTSIDE, USE A SUNSCREEN. IF EXCESSIVE DRYNESS OR BOTHERSOME PEELING OCCURS, REDUCE APPLICATION USE.
  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    • THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS.
    • STORE AT ROOM TEMPERATURE.
    • AVOID STORING AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).
  • INACTIVE INGREDIENT

    INACTIVE NGREDIENTS

    WATER, GLYCERIN, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, ARBUTIN, KOJIC ACID, L-ASCORBIC ACID, SODIUM PCA, ALLANTOIN, PANTHENOL, HYDROGENATED METHYL ABIETATE, PHENOXYETHANOL, FRAGRANCE, METHYLISOTHIAZOLINONE

  • PRINCIPAL DISPLAY PANEL

    DLSC_AcneLotion_2oz_bottleFINAL

    DLSC_AcneLotion_2oz_DF-Box

  • INGREDIENTS AND APPEARANCE
    DR. LIN SKINCARE ACNE 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58876-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ARBUTIN (UNII: C5INA23HXF)  
    KOJIC ACID (UNII: 6K23F1TT52)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERYL ABIETATE (UNII: 2F22LY70Q1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58876-104-1260 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/26/2013
    Labeler - DR LIN SKINCARE (622329980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Westwood Laboratories Inc.069926483manufacture(58876-104) , pack(58876-104)
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