Label: DOANS PAIN RELIEVING- lidocaine and menthol, unspecified form cream

  • 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 June 15, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Lidocaine 4% w/wTopical Anesthetic
    Menthol 1%Topical Analgesic
  • Use

    For the temporary relief of pain

  • Warnings

    For external use only

    Do not use

    • if you have had an allergic reaction to lidocaine, or other local anesthetics
    • over a large area of the body, or on cut, irritated, punctured, blistered, or swollen skin
    • 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 carton.
      Keep this carton for important information.
    • avoid contact with eyes
    • do not bandage or apply local heat (such as heating pads) to the area of use
    • wash hands after applying

    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

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

    Store out of reach of children and pets.

    Dispose of product out of the 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 affected area every 6 to 8 hours
    • do not exceed 3 applications in a 24 hour period

    Children 12 years and younger: ask a doctor

  • Other information

    Store at controlled room temperature 20-25 C (66-78 F). Child resistant packaging. Close cap tightly between uses.

  • Inactive ingredients

    benzyl alcohol, carbomer, lecithin, propylene glycol, purified water, tocopheryl acetate

  • Questions or Comments

    1-800-790-6417

  • PRINCIPAL DISPLAY PANEL - 77.9 g Tube Carton

    Maximum Strength Lidocaine

    Available Without a Prescription

    DOAN'S®
    Pain Relieving Cream
    with
    4%
    LIDOCAINE
    PLUS
    MENTHOL

    DUAL ACTION
    Local Anesthetic + Topical Analgesic

    • NUMBS AWAY PAIN
    • Non-Greasy
    • Fast Acting

    NET WT.
    2.75 oz (77.9g)

    Principal Display Panel - 77.9 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    DOANS PAIN RELIEVING 
    lidocaine and menthol, unspecified form cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55741-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine4 g  in 100 g
    menthol, unspecified form (UNII: L7T10EIP3A) (menthol, unspecified form - UNII:L7T10EIP3A) menthol, unspecified form1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    benzyl alcohol (UNII: LKG8494WBH)  
    carbomer homopolymer type B (Allyl Pentaerythritol crosslinked) (UNII: HHT01ZNK31)  
    lecithin, soybean (UNII: 1DI56QDM62)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55741-002-031 in 1 CARTON05/24/2016
    177.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/24/2016
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)
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