SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]

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SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]
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NDC 62221-935-02
Set ID ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a
Category HUMAN OTC DRUG LABEL
Packager Filltech USA, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Sonacaine Topical Anesthetic Gel With Menthol


  • Drug Facts


  • Active Ingredients

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Uses:

    temporary relieves pain and itching due to:

    • minor cuts
    • sunburn
    • minor scrapes
    • minor burns
    • insect bites
    • minor skin irritations
  • Warnings:

    For external use only.

  • Keep out of reach of children


  • Directions:

    Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.

  • Other Ingredients:

    Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

  • Sonacaine Topical Anesthetic Gel With Menthol 2oz/60g (62221-935-02)

    Sonacaine

  • INGREDIENTS AND APPEARANCE
    SONACAINE TOPICAL ANESTHETIC WITH MENTHOL 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62221-935
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62221-935-0260 g in 1 BOTTLE; Type 0: Not a Combination Product05/02/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/02/2012
    Labeler - Filltech USA, LLC (926433855)
    Registrant - Filltech USA, LLC (926433855)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855manufacture(62221-935)
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