Label: CVS BURN RELIEF W/LIDO 8OZ- lidocaine hcl gel

  • 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 March 23, 2016

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  • Active ingredient

    Lidocaine HCl 0.5%


  • Purpose

    Topical Analgesic


  • Uses

    • Temporarily relieves pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, or 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. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    • irritation or rash develops
    • 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.

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

  • Directions

    • adults and children 2 years and older:apply to affected areas as needed, not more than 3 to 4 times a day
    • children under 2 years:ask a doctor before use
  • Inactive ingredients

    Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice Powder, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.

  • Questions or comments?

    Call toll free 1-800-SHOP CVS

  • Principal Display Panel

    CVS pharmacy

    Compare to Solarcaine

    Burn Relief Gel

    NEW!

    BURN RELIEF GEL

    WITH LIDOCAINE HCl

    RESTORES MOISTURE


    • Soothes and relieves
    • Cooling sunburn relief
    • Topical analgesic gel

    NET WT 8 OZ (226 g)



    Label





  • INGREDIENTS AND APPEARANCE
    CVS BURN RELIEF W/LIDO 8OZ 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-670
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-670-16226 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/08/2015
    Labeler - CVS Pharmacy (062312574)
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