Label: RITE AID SOOTHING MEDICATED ANIT-ITCH- menthol, pramoxine hydrochloride cream

  • 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 July 8, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

    Menthol 1%....................................................Pain Reliever
    Pramoxine Hydrochloride 1%............................External Analgesic
  • PURPOSE



    Uses

    For the temporary relief of pain and discomfort caused by
    - minor burns - sunburn - scrapes - insect bites
    - minor skin irritations - rashes due to poison ivy, oak and sumac
  • 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 pain and discomfort caused by
    - minor burns - sunburn - scrapes - insect bites
    - minor skin irritations - rashes due to poison ivy, oak and sumac
  • WARNINGS

    Warnings

    - For external use only
    - Avoid contact with the eyes

    Do Not use     - under bandages or compresses

    Stop use and ask a doctor if condition worsens, or if 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 2 times daily

    - Children under 2 years of age:     do not use, consult a doctor

    Other information

    Store at room temperature. Lot No. and Exp. Date: see crimp of tube or see box.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    aloe barbadensis leaf juice, diazolidinyl urea, disodium EDTA, eucalyptus globules leaf oil, iodopropynyl butylcarbamate, methyl salicylate,
    petrolatum, PPG-1 trideceth-6, propylene glycol, purified water, sodium acrylates copolymer, steareth-2 steareth-21, stearyl alcohol, thymol,
    tocopheryl acetate, triethanolamine

  • PRINCIPAL DISPLAY PANEL


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  • INGREDIENTS AND APPEARANCE
    RITE AID SOOTHING MEDICATED ANIT-ITCH 
    menthol, pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARETH-2 (UNII: V56DFE46J5)  
    THYMOL (UNII: 3J50XA376E)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0415-11 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/08/2010
    Labeler - RITE AID CORPORATION (014578892)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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