Label: DCH PAIN RELIEF- lidocaine 4% spray

  • NDC Code(s): 72839-226-04
  • Packager: Derma Care Research Labs, LLC
  • 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 July 20, 2023

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  • ACTIVE INGREDIENT

    Lidocaine 4%

  • PURPOSE

    External Analgesic.

  • DOSAGE & ADMINISTRATION

    For the temporary relief of pain and itching due to sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritations.

  • WARNINGS

    For external use only.

    Flammable--Do not use while smoking or near heat or flame.

    Do not use in large quantities, particularly over raw surfaces or blistered areas.

    When using this product avoid contact with eyes. Rinse eyes with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

    Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days, irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 2 years of age: consult a physician. To apply to face, squeeze into palm of hand and gently apply.

  • INACTIVE INGREDIENT

    Water, Glycerin, Alcohol Denat., Propylene Glycol, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Simethicone.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DCH PAIN RELIEF 
    lidocaine 4% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-226
    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
    CUCUMBER (UNII: YY7C30VXJT)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-226-04113 g in 1 CAN; Type 0: Not a Combination Product06/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/10/2021
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs116817470manufacture(72839-226)
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