Label: CUTAR- coal tar lotion

  • NDC Code(s): 11086-105-01, 11086-105-02
  • Packager: Summers Laboratories Inc
  • 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 February 3, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    7.5% L.C.D. (EQUIVALENT TO 1.5% COAL TAR)

  • PURPOSE

    PURPOSE

    PSORIASIS, SEBORREIC DERMATITIS TREATMENT

  • INDICATIONS & USAGE

    USE

    • CONTROLS ITCHING, FLAKING AND REDNESS DUE TO PSORIASIS AND SEBORRHEIC DERMATITIS
  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • ASK DOCTOR

    ASK A DOCTOR BEFORE USE IF YOU HAVE

    • CONDITION THAT COVERS A LARGE AREA OF THE BODY
    • CONDITION IN OR AROUND THE RECTUM, GENITAL AREA OR GROIN
  • WHEN USING

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER
    • USE CAUTION IN EXPOSING SKIN TO SUNLIGHT AFTER APPLYING THIS PRODUCT. IT MAY INCREASE YOUR TENDENCY TO SUNBURN FOR UP TO 24 HOURS AFTER APPLICATION
  • DO NOT USE

    DO NOT USE

    • FOR PROLONGED PERIODS WITHOUT CONSULTING A DOCTOR
    • WITH OTHER FORMS OF PSORIASIS THERAPY UNLESS DIRECTED TO DO SO BY A DOCTOR
  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    • CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE AS DIRECTED
    • EXCESSIVE 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
    • TO PREVENT STAINING DO NOT USE IN PLASTIC OR FIBERGLASS TUBS, SINKS OR BASINS. CUTAR MAY STAIN LIGHT COLORED FABRICS
  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • APPLY TO AFFECTED AREAS ONE TO FOUR TIMES DAILY OR AS DIRECTED BY A DOCTOR
    • AS A MEDICATED LOTION: GENTLY RUB A SMALL AMOUNT ONTO AFFECTED AREAS. BLOT OFF EXCESS WITH A TISSUE TO HELP PREVENT STAINING OF CLOTHING OR LINENS
    • IN THE BATH: POUR A LIBERAL QUANTITY (2 TO 4 OZ.) INTO THE TUB, MAKING SURE CUTAR IS WELL MIXED. SOAK FOR 10 TO 20 MINUTES, OR AS DIRECTED BY YOUR DOCTOR. AFTER TREATMENT, PAT SKIN DRY.
    • GUARD AGAINST SLIPPING.
    • AS A HAND OR FOOT SOAK: ADD 1 TO 2 OZ. TO A SINK OR BASIN. MIX WELL AND SOAK FOR 5 TO 10 MINUTES OR AS DIRECTED BY YOUR DOCTOR.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    WATER, MINERAL OIL, ISOPROPYL MYRISTATE, POLYSORBATE 80, SORBITAN SESQUIOLEATE, LANOLIN ALCOHOLS EXTRACT, METHYL AND PROPYL PARABENS, FRAGRANCE, XANTHAN GUM, CARBOMER

  • PRINCIPAL DISPLAY PANEL

    CUT6 label 0417

  • INGREDIENTS AND APPEARANCE
    CUTAR 
    coal tar lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11086-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11086-105-01180 mL in 1 BOTTLE; Type 0: Not a Combination Product10/29/2013
    2NDC:11086-105-023785 mL in 1 JUG; Type 0: Not a Combination Product10/29/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/29/2013
    Labeler - Summers Laboratories Inc (002382612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Summers Laboratories Inc002382612manufacture(11086-105)