PAIN RELIEF (LIDOCAINE HCL) CREAM [TOPCO]

PAIN RELIEF (LIDOCAINE HCL) CREAM [TOPCO]
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NDC 36800-740-03
Set ID 58cb1b71-2343-4283-bd5f-4ece0cc92ae2
Category HUMAN OTC DRUG LABEL
Packager Topco
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Active ingredient                                               Purpose

    Lidocaine HCl 4%                                              Topical Analgesic

  • PURPOSE

  • Uses

    Uses For temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritation

  • Warnings

    ​For external use only

    When using this product • avoid contact with eyes • do not use in large quantities, particularly over raw surfaces or blistered areas.

    Stop use and ask a doctor if • condition worsens • symptoms last 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 affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, 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 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-740
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    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:36800-740-0377 g in 1 CONTAINER; Type 0: Not a Combination Product11/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/17/2017
    Labeler - Topco (006935977)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(36800-740) , label(36800-740)

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