Label: SUNBURN PAIN RELIEVER CVS- lidocaine hydrochloride 0.5% 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 November 30, 2017

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  • Active ingredient                                             Purpose

    Lidocaine Hydrochloride 0.5%                         Pain Reliever

  • PURPOSE

  • Uses for temporary relief of pain and itching due to

    • sunburn
    • minor burns
    • insect bites
    • cuts
    • scrapes
  • 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 last more than 7 days.

    Keep out of reach of the children

  • Directions

    • adults and children 2 years of age and older: apply to affected area, not more than 3 to 4 times a day
    • children under 2 years of age: consult a physician

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUNBURN PAIN RELIEVER  CVS
    lidocaine hydrochloride 0.5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-840
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Menthol (UNII: L7T10EIP3A)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-840-06226 g in 1 BOTTLE; Type 0: Not a Combination Product01/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/18/2017
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-840) , label(69842-840)
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