TOPICAL PAIN RELIEF (LIDOCAINE HCL) LIQUID [LEON MEDICAL CENTERS, INC]

TOPICAL PAIN RELIEF (LIDOCAINE HCL) LIQUID [LEON MEDICAL CENTERS, INC]
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NDC 89076-1095-7
Set ID 1198a56b-9719-41c9-9a8c-2fafe68f46c5
Category HUMAN OTC DRUG LABEL
Packager LEON MEDICAL CENTERS, INC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Lidocaine HCl, USP 4%

  • PURPOSE

    Topical Anesthetic

  • INDICATIONS & USAGE

    Use

    Temporarily relieves minor pains

  • WARNINGS

    Warnings

    For external use only

    Do not use

    • on large areas of the body or on cut, irritated, or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    When using this product

    • use only as directed. Read and follow all directions and warnings on this label
    • do not allow contact with eyes
    • do not handage or apply local heat (such as heating pads) to the area of use.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a doctor before use. 

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children over 12 years of age
    • Apply generously to the affected area as needed every 6-8 hours, not to exceeed 3 application in a 24 hour period.
    • Not for use in children under 12 years of age
  • INACTIVE INGREDIENT

    Inactive ingredients

    camphor, glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water and xantham gum.

  • PRINCIPAL DISPLAY PANEL

    RollOnLabel

  • INGREDIENTS AND APPEARANCE
    TOPICAL PAIN RELIEF 
    lidocaine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:89076-1095
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:89076-1095-760 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2018
    Labeler - LEON MEDICAL CENTERS, INC (947237210)

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