PAIN RELIEF SIGNATURE CARE (LIDOCAINE HCL 4%) CREAM [BETTER LIVING]

PAIN RELIEF SIGNATURE CARE (LIDOCAINE HCL 4%) CREAM [BETTER LIVING]
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NDC 21130-767-03
Set ID 88b830da-5a42-48f5-a3b0-17dddef3864a
Category HUMAN OTC DRUG LABEL
Packager Better Living
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

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

  • PURPOSE

  • INDICATIONS & USAGE

    Uses
    For temporary relief of pain associated with pain or itching like minor burns, sunburns, minor cuts, insect bites, skin irritation

  • 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

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  SIGNATURE CARE
    lidocaine hcl 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-767
    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)  
    Steareth-21 (UNII: 53J3F32P58)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-767-031 in 1 CARTON03/15/2018
    176.5 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/15/2018
    Labeler - Better Living (009137209)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(21130-767) , label(21130-767)

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