Label: DOLOGESIC ROLL-ON- lidocaine hcl liquid

  • NDC Code(s): 54859-513-02
  • Packager: Llorens Pharmaceutical International Division, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 23, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient

    Lidocaine HCL, USP 4% 

  • PURPOSE

    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 bandage or apply local heat (such as heating pads) to the area of use.

    Stop use and ask 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 exceed 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.

  • QUESTIONS

    Questions

    Llorens Pharmaceutical International Division, Inc.

    Miami Fl 33147

  • PRINCIPAL DISPLAY PANEL

    DologesicRollOn

  • INGREDIENTS AND APPEARANCE
    DOLOGESIC ROLL-ON 
    lidocaine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-513
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 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:54859-513-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2018
    Labeler - Llorens Pharmaceutical International Division, Inc. (037342305)
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