Label: PAIN RELIEF CVS- lidocaine 4% liquid

  • 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 December 20, 2017

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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 • shake well • 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

     Aloe Barbadensis Leaf Juice, SD Alcohol 40, Propylene Glycol, Glycerin,
    Simethicone, Tocopheryl Acetate, Triethanolamine, Carbomer,
    Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium
    Cocoamphodipropionate, Disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  CVS
    lidocaine 4% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-049
    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:69842-049-05133 mL in 1 CAN; Type 0: Not a Combination Product01/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/31/2017
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-049)
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