Label: PAIN RELIEF ROLL-ON- lidocaine hci gel

  • 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 20, 2016

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  • ACTIVE INGREDIENT

    Active ingredient                                              Purpose
    Lidocaine HCl 4%..............................................Topical anesthetic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses For temporary relief of pain and itching

  • WARNINGS

    Warnings
    For external use only.
    When using this product • use only as directed • do not bandage tightly • avoid contact with eyes • do not apply to wounds or damaged skin • do not use in large quantities, particularly over raw surfaces or blistered areas.
    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

  • 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: consult a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis
    Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl
    Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol,
    Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium
    EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, SD
    Alcohol 40, Steareth-21, Water.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF ROLL-ON 
    lidocaine hci gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7780
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Ceteth-20 Phosphate (UNII: 921FTA1500)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    ALCOHOL (UNII: 3K9958V90M)  
    Steareth-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7780-0374 mL in 1 CONTAINER; Type 0: Not a Combination Product07/08/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/08/2016
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(0363-7780)
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