Label: WARRIOR BURN RELIEF ALOE MAXIMUM STRENGTH- lidocaine hcl 4% gel

  • NDC Code(s): 72839-185-04
  • 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 November 1, 2022

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  • ACTIVE INGREDIENT

    Lidocaine HCl 4%

  • PURPOSE

    Pain Relief

  • DOSAGE & ADMINISTRATION

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

  • WARNINGS

    For external use only.

    When using this product avoid contact with eyes. Rinse with water if contact occurs. Stop use and ask a doctor if symptoms persist for more than 7 days. Do not use in large quantities, particularly over raw surfaces or blistered areas.

  • 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 2 years and older: apply to the affected area, not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Blue 1, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Glycerin, Hydroxyethylcellulose, Isopropyl Alcohol, Phenoxyethanol, Polysorbate 20, Propanediol, Tocopheryl Acetate, Water.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    WARRIOR BURN RELIEF ALOE  MAXIMUM STRENGTH
    lidocaine hcl 4% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    OATMEAL (UNII: 8PI54V663Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-185-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/25/2022
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-185)
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