SUNBURN PAIN RELIEF (LIDOCAINE HYDROCHLORIDE 0.5%) GEL [TOP CARE]

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SUNBURN PAIN RELIEF (LIDOCAINE HYDROCHLORIDE 0.5%) GEL [TOP CARE]
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NDC 36800-883-06
Set ID caf83b63-604e-43ae-85a0-b31db5fd2388
Category HUMAN OTC DRUG LABEL
Packager Top Care
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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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
    SUNBURN PAIN RELIEF 
    lidocaine hydrochloride 0.5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-883
    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 mL
    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:36800-883-061 in 1 CARTON02/12/2016
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/12/2016
    Labeler - Top Care (006935977)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(36800-883) , label(36800-883)
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