BURN (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

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BURN (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
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NDC 50382-022-11, 50382-022-12, 50382-022-13
Set ID 9abedfe3-52fa-44f5-b489-5c42b80c9348
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Private Limited
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

  • • PURPOSE

    Topical antiseptic

    Topical analgesic

  • • USES

    • For temporary relief of pain and itching associated with:
      • sunburn
      • minor burns
      • insect bites
      • minor skin irritation
      • cuts
      • scrapes
  • • WARNINGS

    For external use only.

    • 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

    • Stop use and ask a doctor if
      • the condition gets worse
      • condition clears up and recurs within a few days
      • condition persists for more than 7 days
      • if pregnant or breast feeding, ask a health care professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • • DIRECTIONS

    Adults and children 2 years and over:

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

    Children under 2 years

    • consult a doctor
  • • OTHER INFORMATION

    • store in a cool, dry area 59° to 79° F (15° to 25° C)
    • tamper evident sealed packets
    • do not use any open or torn packets
  • • INACTIVE INGREDIENTS

    Butylated hydroxytoluene, Cetomacrogol, Cetostearyl alcohol, Dimethicone, Glycerine, Glyceryl monostearate, Isopropyl myristate, Methylcellulose, Sodium EDTA, Sodium methylparaben, Sodium propylparaben, Purified Water

  • SPL UNCLASSIFIED SECTION

    Manufactured by :

    Galentic Pharma (India) Pvt. Ltd.,

    Plot No. 5-B & 5-C, Sector III,

    Kandla Special Economic Zone,

    Gandhidham-370 230, Gujarat. India

  • PRINCIPAL DISPLAY PANEL - 0.9 gram Packet Carton

    NDC # 50382-022-12

    GALENTIC
    Burn Cream with Lidocaine

    Antiseptic and pain relieving cream
    for minor cuts, scrapes and burns

    0.9 gram Packets
    25 per box

    Principal Display Panel - 0.9 gram Packet Carton
  • INGREDIENTS AND APPEARANCE
    BURN 
    lidocaine hydrochloride and benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-022-1110 in 1 CARTON04/14/2016
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50382-022-1225 in 1 CARTON04/14/2016
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50382-022-13144 in 1 CARTON09/01/2015
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2015
    Labeler - Galentic Pharma (India) Private Limited (915110464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Private Limited650970176analysis(50382-022) , manufacture(50382-022) , pack(50382-022) , repack(50382-022) , sterilize(50382-022)
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