Label: DCH BURN RELIEF- lidocaine hcl gel

  • NDC Code(s): 72839-955-08
  • 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 June 27, 2023

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  • ACTIVE INGREDIENT

    Lidocaine HCl 0.5%

  • 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.

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

    When using this product avoid contact with eyes. Rinse with water if contact occurs.

    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.

  • 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, Isopropyl Alcohol, Aloe Barbadensis Leaf Extract, Menthol, Propylene Glycol, Polysorbate 80, Triethanolamine, Carbomer, Disodium EDTA, Blue 1, Yellow 5, Diazolidinyl Urea.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DCH BURN RELIEF 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-955
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-955-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/11/2021
    Labeler - Derma Care Research Labs, LLC (116817470)
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