Label: MAXIMUM STRENGTH MEDICATED ANTI-ITCH RITE AID- menthol 1 % pramoxine hydrochloride 1 % cream

  • 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 October 3, 2017

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  • Active ingredients                                     Purpose

    Menthol – 1.00%                                      External Analgesic   
    Pramoxine Hydrochloride – 1.00%            External Analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    ​Uses​ For temporarily relief of pain and itching associated with:• sunburn • minor burns • scrapes • insect bites • minor skin irritation • minor cuts • rashes due to poison ivy, oak & sumac

  • WarningsFor external use only

    When using this product • Avoid contact with eyes • not for prolonged use

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persisit more than 7 days or clear up and occur again within a few days

    Keep out of reach of the children. If product is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Adults and children 2 years of age and older:​ apply to the affected area no more than 4 times daily
    • Children under 2 years of age: consult a doctor
  • Other information

    Store at room temperature.

  • Inactive ingredients

    Water, Propylene Glycol, Petrolatum, Stearyl Alcohol, Aloe Barbadensis Leaf Juice, Sodium Acrylates Copolymer, Steareth-21, Mineral Oil,
    Steareth-2, Tocopheryl Acetate, Thymol, Eucalyptol, Methyl Salicylate, PPG-1 Trideceth-6, Diazolidinyl Urea, Disodium EDTA, Triethanolamine,
    Iodopropynyl Butylcarbamate

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH MEDICATED ANTI-ITCH  RITE AID
    menthol 1 % pramoxine hydrochloride 1 % cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7777
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol1 g  in 100 g
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) Pramoxine Hydrochloride1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Steareth-21 (UNII: 53J3F32P58)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Steareth-2 (UNII: V56DFE46J5)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Thymol (UNII: 3J50XA376E)  
    Eucalyptol (UNII: RV6J6604TK)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    PPG-1 Trideceth-6 (UNII: 1K7417JX6Q)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-7777-11 in 1 CARTON05/22/2013
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/22/2013
    Labeler - Rite Aid (014578892)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(11822-7777) , label(11822-7777)
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