PLUM SMOOTH PLUMB NUMB GELEE (LIDOCAINE) GEL [UNIVERSAL COMPANIES, INC.]

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PLUM SMOOTH PLUMB NUMB GELEE (LIDOCAINE) GEL [UNIVERSAL COMPANIES, INC.]
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NDC 49911-884-01
Set ID 6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e
Category HUMAN OTC DRUG LABEL
Packager Universal Companies, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Plum Smooth Plumb Numb Gelee

  • Active Ingredients

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Uses

    For the temporary relief of discomfort and pain

  • Directions

    Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily

  • Warnings

    For external use only

    Avoid contact with eyes

  • Do not use

    In large quantities, particularly over raw surfaces or blistered areas

  • STOP USE

    • skin becomes irritated
    • condition worsens or symptoms last more than 7 days
    • symptoms clear up and reoccur within a few days
  • Inactive 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

  • Distributed by:

    Universal Companies, Inc. Abingdon, VA 24210

  • Plum Smooth Plumb Numb Gelee 1oz/28.35g

    PlumSmoothLabel

  • INGREDIENTS AND APPEARANCE
    PLUM SMOOTH PLUMB NUMB GELEE 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49911-884
    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)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)  
    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:49911-884-0128.35 g in 1 BOTTLE; Type 0: Not a Combination Product03/29/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/29/2012
    Labeler - Universal Companies, Inc. (127169782)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855manufacture(49911-884)
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