Label: WELAHEAD BY WELMATE LIDOCAINE 5% ROLL-ON- lidocaine 5% solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 1, 2023

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  • Active Ingredient

    Lidocaine HCl 5%

  • Purporse

    Topical Analgesic

  • Use

    Temporarily Relieves minor pain

  • 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 week without consulting a doctor

    When using this product:

    • use cnly as directed. Read and follow all directions and warnings on this carton
    • do not allow contact with the eyes and mucous membranes
    • do not bandage or apply a local heat (such as heating pads) to the area of use

    Stop use and aska doctor if

    • condition worsens
    • skin reactions occur, such as rash, itching, redness, irritation, pain, and swelling
    • symptoms persist for more than 7 days or clear up and occur again within a days

    Flammable

    • keep away from fire or flame

    If pregnant or breast freding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children over 12 years:

    apply a thin layer to affeced area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

    Children 12 years and younger: ask a doctor

  • Inactive Ingrediants

    purified water, ethyl alcohol, propylene glycol, polysorbate 20, triethanolamine, phenoxyethanol, ethylhexylglycerin,

    potassium carbomer, aloe vera, glycerin, chonüoitin sulfate, glucosamine sulfate, methylsulfonylmethane

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    WELAHEAD BY WELMATE LIDOCAINE 5% ROLL-ON 
    lidocaine 5% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83833-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83833-101-0390 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/01/2023
    Labeler - OTC PHARM LLC (119131224)
    Registrant - OTC PHARM LLC (119131224)