Label: CVS FRAGRANCE FREE ANTI-ITCH- pramoxine hydrochloride 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 8, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

    Pramoxine Hydrochloride...................................External Analgesic


  • PURPOSE



    Uses

    For the temporary relief 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 temporary relief of itching associated with minor skin irritations
  • WARNINGS

    Warnings

    For external use only

    When using this product
    - avoid contact with eyes

    Stop use and ask a doctor if
    - condition worsens
    - 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.
  • DOSAGE & ADMINISTRATION


    Directions

     adults and children 2 years and older

    - apply to affected area not more than 3 to 4 times daily

    children under 2 years of age

    - consult a doctor


  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, isopropyl myristate, stearic acid, glyceryl stearate, PEG-100 stearate, cetyl alcohol,
    PEG-8, petrolatum, dimethicone, benzyl alcohol, carbomer, sodium hydroxide
  • PRINCIPAL DISPLAY PANEL


    c


  • INGREDIENTS AND APPEARANCE
    CVS FRAGRANCE FREE ANTI-ITCH 
    pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-052-5880 mL in 1 BOTTLE, PUMP
    2NDC:59779-052-59222 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/08/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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