Label: CVS SOOTHING ITCH RELIEF- menthol 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 July 10, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

    Menthol 0.1%..................................................External analgesic lotion
  • PURPOSE



    Uses     for the treatment of itching associated with minor skin irritations.
  • 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


    Uses for the treatment of itching associated with minor skin irritations.
  • WARNINGS

    Warnings

    For external use only


    When using this product     avoid contact with the eyes

    Stop use and ask a doctor if
    - condition worsens - irritation occurs
    - symptoms persist for more than  7 days, or clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison
    Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
  • DOSAGE & ADMINISTRATION


    Directions

    Adults and children 2 years of age and older,
    - apply to afected area not more than 3 to 4 times daily

    Children under 2 years of age,

    - consult a doctor


  • INACTIVE INGREDIENT

    Inactive Ingredients


    acrylates/C10-30 alkyl acrylate crosspolymer, benzyl alcohol, caprylic/capric triglyceride,
    cetearyl alcohol, cetyl alcohol, colloidal oatmeal, dimethicone, DMDM hydrantoin, glycerin,
    glyceryl stearate SE, isopropyl isostearate, myristyl, myristate, octyldodecanol,
    oenothera biennis oil (evening primrose), PEG-40 castor oil, phenoxyethanol,
    polyglyceryl-3 methylglucose distearate, potassium sorbate, purified water, sodium citrate
  • PRINCIPAL DISPLAY PANEL



    c

  • INGREDIENTS AND APPEARANCE
    CVS SOOTHING ITCH RELIEF 
    menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OATMEAL (UNII: 8PI54V663Y)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-051-37200 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/10/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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