SOLARCAINE COOL ALOE (LIDOCAINE HYDROCHLORIDE) GEL [BAYER HEALTHCARE LLC.]

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SOLARCAINE COOL ALOE (LIDOCAINE HYDROCHLORIDE) GEL [BAYER HEALTHCARE LLC.]
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NDC 11523-0430-2, 11523-0430-3
Set ID 88f3cb40-2258-4e1c-92fb-e1891ddb3135
Category HUMAN OTC DRUG LABEL
Packager Bayer HealthCare LLC.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine hydrochloride 0.5%

  • Purpose

    External analgesic

  • Uses

    temporarily relieves pain and itching due to:

    • minor skin irritations
    • minor burns
    • sunburn
    • scrapes
    • minor cuts
    • insect bites
  • Warnings

    For external use only

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

    When using this product keep out of eyes

    Stop use and ask a doctor if

    • condition gets worse
    • symptoms last more than 7 days
    • symptoms clear up and occur again in 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 of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • Inactive Ingredients

    aloe barbadensis leaf juice, water, propylene glycol, glycerin, triethanolamine, isopropyl alcohol (0.06% v/v), polysorbate 80, carbomer, diazolidinyl urea, menthol, disodium EDTA, yellow 5, blue 1

  • PRINCIPAL DISPLAY PANEL - 226g Bottle Label

    Cools Instantly!

    #1

    SUNBURN

    RELIEF BRAND

    Solarcaine     ®

    cool aloe

    BURN RELIEF FORMULA

    Pain Relieving Gel with Lidocaine HCl

    Restores Moisture

    to Sunburned Skin

    Doctor Tested

    NET WT 8 OZ (226g)

    pdp

    dfl

  • INGREDIENTS AND APPEARANCE
    SOLARCAINE COOL ALOE 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0430
    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)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL (UNII: L7T10EIP3A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0430-2226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2016
    2NDC:11523-0430-3340 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/13/2012
    Labeler - Bayer HealthCare LLC. (112117283)
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