BURN (LIDOCAINE HYDROCHLORIDE) GEL [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

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BURN (LIDOCAINE HYDROCHLORIDE) GEL [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
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NDC 50382-020-11, 50382-020-12, 50382-020-13, 50382-020-14
Set ID 8c9f0313-9e06-4f7c-97bc-fb4b421ef8c7
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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  • • ACTIVE INGREDIENT

    Lidocaine Hydrochloride2%

  • • PURPOSE

    Analgesic

  • • USES

    • For temporary relief of pain and itching associated with:
      • sunburn
      • minor burns
      • Provides cooling pain relief
  • • WARNINGS

    For external use only.

    • Do not use

    • On wounds or damaged skin
    • In large quantities, particularly over raw surfaces or blistered areas.

    • When using this product

    • Avoid contact with the eyes
    • Do not bandage tightly

    • Stop use and ask a doctor if

    • the condition gets worse
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

    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:

    • Apply to affected area not more than 3 to 4 times daily
    • Children under 2 years of age: Consult a doctor
  • • OTHER INFORMATION

    • store at room temperature
  • • INACTIVE INGREDIENTS

    Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, Triethanolamine.

  • 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 - 3.5 g Packet Carton

    Manufactured by :

    Galentic Pharma (India) Pvt. Ltd.,

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

    Kandla Special Economic Zone,

    Gandhidham-370 230, Gujarat. India

    Made in India

    BURN Gel

    Galentic

    3.5 g packets

    6 Per Box

    NDC # 50382-020-12

    PRINCIPAL DISPLAY PANEL - 3.5 g Packet Carton

  • INGREDIENTS AND APPEARANCE
    BURN 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    IMIDUREA (UNII: M629807ATL)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-020-126 in 1 CARTON09/07/2017
    13.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50382-020-1325 in 1 CARTON09/07/2017
    23.5 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50382-020-141728 in 1 CARTON09/07/2017
    33.5 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:50382-020-11144 in 1 CARTON04/01/2018
    40.9 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 finalpart34809/07/2017
    Labeler - Galentic Pharma (India) Private Limited (915110464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Private Limited650970176analysis(50382-020) , manufacture(50382-020) , pack(50382-020) , repack(50382-020) , sterilize(50382-020)
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