Label: DCH NERVE PAIN RELIEF- lidocaine 4%, menthol 1% spray

  • NDC Code(s): 72839-223-05
  • 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 19, 2023

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  • ACTIVE INGREDIENT

    Lidocaine 4%, Menthol 1%

  • PURPOSE


    Topical anesthetic, Topical analgesic

  • INDICATIONS & USAGE

    Temporarily relieves minor pain

  • WARNINGS

    For external use only.

    Flammable--Keep away from fire or flame.

    Do not use if you have had an allergic reaction to lidocaine or other local anesthetics, on large areas of he body or on cut, irritated, blistered or swollen skin, on puncture wounds, for more than one week without consulting a doctor.

    When using this product only use as directed, avoid contact with eyes and mucous membranes, rare cases of serious burns have been reported with products of this type, do not apply to wounds or damaged, broken, or irritated skin, do not bandage tightly or apply local heat (such as heating pads) or a medicated path to the area of use, a transient burning sensation may occur upon application but generally disappears in several days, avoid applying into skin folds.

    Stop use and ask a doctor if condition worsens, severe burning sensation, redness, rash or irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

    .

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    When practical, cleanse the affected area with mild soap and warm water, Rinse thoroughly and gently pat dry. Spray affected area. Wash hands after applying. Adults and children 2 years of age and older, apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor.

  • INACTIVE INGREDIENT

    Alcohol denat., caprylic/capric triglyceride, propylene glycol, arnica montana flower extract, anthemis nobilis flower oil, aloe barbadensis leaf extract, eucalyptus globulus leaf oil.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DCH NERVE PAIN RELIEF 
    lidocaine 4%, menthol 1% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-223
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-223-05142 g in 1 CAN; Type 0: Not a Combination Product03/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/24/2023
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-223)