DYNAREX BURN CREAM (LIDOCAINE) CREAM [DYNAREX CORPORATION]

DYNAREX BURN CREAM (LIDOCAINE) CREAM [DYNAREX CORPORATION]
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NDC 67777-412-01
Set ID b3fe8c85-03cd-44d9-8c28-edb9c05a8115
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Active Ingredients

    Active Ingredient                                       Purpose

    Lidocaine HCL 0.5%                                   Topical Analgesic

    Benzalkonium Chloride 0.13%                    Topical Antiseptic

  • Purpose

    Temporary relief of pain and itching.

  • Uses

    For temporary relief of pain and itching associated with:

    • Sunburn
    • Minor burns,
    • Insect bites,
    • Minor skin irritation,
    • Cuts and 
    • Scrapes
  • Warnings

    FOR EXTERNAL USE ONLY

  • 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.

  • Stop Use

    Stop Use and ask a doctor:

    • If condition worsens or,
    • if symptoms persist for more than 7 days or clear up and occur again in a few days.
    • If pregnant or breast feeding, ask a health professional before use.

  • Do Not Use

    Do Not Use:

    • In the eyes
    • Over large areas of the body or on deep puncture wounds, animal bites or serious burns.
    • In large quantities, particularly over raw surfaces or blistered areas.
  • Directions

    Adults and children 2 years and over:

    • clean the affected area
    • apply a small amount of this product on the area 3 or 4 times daily.
    • may be covered with a sterile bandage

    Children under 2 years

    • consult a doctor
  • Inactive ingredients

    Buttylated hydroxy toluene, Cetomacrogol, Cetostearyl alcohol, Dimethicone, Glycerine, Glyceryl monostearate, Isopropyl myristate, Methylcellulose, Purified water, Sodium EDTA, Sodium methylparaben, Sodium propylparaben

  • Other Information

    Other Information

    • store in a cool, dry area
    • 59o to 79o F (15o to 25o C)
    • Tamper evident sealed packets do not use any open or torn packets
  • Principal Display Panel

    Dynarex Burn Cream 

    DFAC.jpg

    Burn Cream

  • INGREDIENTS AND APPEARANCE
    DYNAREX BURN CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETETH-20 (UNII: I835H2IHHX)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-412-010.9 g in 1 PACKET; Type 0: Not a Combination Product09/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2015
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Pvt. Ltd.650970176manufacture(67777-412)

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