Label: BURN RELIEF ALOE DAYLOGIC- 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 May 14, 2018

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  • Active ingredient                                             Purpose

    Lidocaine Hydrochloride 0.5%                        External analgesic

  • 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
    BURN RELIEF ALOE  DAYLOGIC
    lidocaine hydrochloride 0.5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7782
    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)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Menthol (UNII: L7T10EIP3A)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-7782-6237 g in 1 BOTTLE; Type 0: Not a Combination Product08/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/30/2016
    Labeler - Rite Aid (014578892)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(11822-7782) , label(11822-7782)
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