CVS SOOTHING ITCH RELIEF (MENTHOL) LOTION [CVS PHARMACY]

CVS SOOTHING ITCH RELIEF (MENTHOL) LOTION [CVS PHARMACY]
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NDC 59779-051-37
Set ID 3d57aa25-8819-49fb-95da-2cdd20dc51f1
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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