Label: DCH PAIN RELIEF- lidocaine hcl 4% cream

  • NDC Code(s): 72839-361-02
  • 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Lidocaine HCl 4%

  • PURPOSE

    Topical Analgesic

  • DOSAGE & ADMINISTRATION

    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 one week without consulting a doctor.

    When using this product use only as directed. Read and follow directions on this carton, avoid contact with eyes and mucous membranes, 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 patch to the area of use, do not use at the same time as other topical analgesics, 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 the condition worsens, redness is present, 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

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Adults and children over 12 years: apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period. AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

    Children under 12 years or younger: ask a doctor.

  • INACTIVE INGREDIENT

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, Steareth-21, Water.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    DCH PAIN RELIEF 
    lidocaine hcl 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-361
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARETH-21 (UNII: 53J3F32P58)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)  
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-361-0276.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/10/2021
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-361)