Label: DCH NUMBING RELIEF- lidocaine 5% spray

  • NDC Code(s): 72839-173-05
  • Packager: Derma Care Research Labs, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 6, 2023

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  • ACTIVE INGREDIENT

    Lidocaine 5%

  • PURPOSE


    Topical anesthetic

  • INDICATIONS & USAGE

    For the local itching and pain associated with anorectal disorders or inflammation.

  • WARNINGS

    For external use only. Flammable--Keep away from fire or flame.

    When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator, contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F.

    Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. i

  • 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

    Water, alcohol denat., propylene glycol, glycerin, aloe barbadensis leaf extract, tocopheryl acetate, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, disodium cocoamphodipropionate, carbomer, disodium EDTA, triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DCH NUMBING RELIEF 
    lidocaine 5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-173-05142 g in 1 CAN; Type 0: Not a Combination Product05/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01501/30/2023
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-173)