Label: MEDICATED PAIN RELIEF FOOT CVS- lidocaine 4% spray

  • 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 May 29, 2018

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  • ACTIVE INGREDIENT

    Active ingredient                                                         Purpose
    Lidocaine 4%................................................................External analgesic

  • PURPOSE

  • Uses

     Temporarily relieves pain and itching due to: • sunburn • minor burns • minor cuts • scrapes • insect bites • minor skin irritations

  • WarningsFor external use only.


    Flammable: Do not use while smoking or near heat or flame Do not use in large quantities, particularly over raw surfaces or blistered areas
    When using this product
    • keep out of eyes
    • use only as directed.
    • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.
    Stop use and ask doctor if
    • condition gets worse • symptoms last more than 7 days
    • symptoms clear up and occur again in a few days

  • 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

  • DOSAGE & ADMINISTRATION

    Directions • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor • to apply to face, spray into palm of hand and gently apply

  • Inactive ingredients

    Alcohol Denat.
    Aloe Barbadensis Leaf Extract
    Carbomer
    Chamomilla Recutita (Matricaria) Flower Extract
    Cucumis Sativus (Cucumber) Fruit Extract
    Diazolidinyl Urea
    Disodium Cocoamphodipropionate
    Disodium EDTA
    Glycerin
    Propylene Glycol
    Simethicone
    Tocopheryl Acetate
    Triethanolamine
    Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MEDICATED PAIN RELIEF FOOT  CVS
    lidocaine 4% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7799
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-7799-4133 mL in 1 CAN; Type 0: Not a Combination Product03/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/08/2018
    Labeler - Rite Aid (014578892)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(11822-7799) , label(11822-7799)