Label: COOLING GEL- 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 July 15, 2019

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  • Active ingredient

    Lidocaine HCI 0.5%

  • Purpose

    Topical Analgesic

  • Uses

    • temporary relief of pain and itching associated with
    sunburn, minor burns, minor cuts, scrapes, minor
    skin irritations and insect bites.

  • Dosage & Administration

    For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, and poison oak.

  • Warnings

    For external use only

  • Do not use

    Do not use this in large quantities, particulary over raw
    surfaces or blistered areas.

  • When using this product

    When using this product avoid contact with eyes.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if condition worsens or if
    symptoms persist for more than 7 days or symptoms
    clear up and occur again within a few days.

  • Keep out of reach of children.

    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: do not use, ask a doctor.

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Blue 1, Carbomer, Disodium
    EDTA, Glycerin, Menthol,
    Phenoxyethanol, Polysorbate 20,
    Propanediol, SD Alcohol (1.85%
    w/w), Sodium Hydroxide, Water,
    Yellow 5

  • Questions or comments?

    Questions or comments?
    1-800-925-4733

  • Principal Display Panel

    Walgreens

    Compare to Solarcaine

    active ingredient

    Cooling Gel

    LIDOCAINE HCl 0.5% /

    PAIN RELIEVER

    SOOTHES & RELIEVES PAIN

    RESTORES MOISTURE

    • For minor cuts & scrapes,

    insect bites, burns & sunburn

    • Topical analgesic
    • Contains aloe vera

    NET WT 8OZ (226 g)

    PKLA-41206-WGF1

    WALG COOLING GEL 8 oz_Front Label.jpg

    WALG COOLING GEL 8 oz_Back Label.jpg

  • INGREDIENTS AND APPEARANCE
    COOLING GEL 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8897
    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
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8897-34226 g in 1 BOTTLE; Type 0: Not a Combination Product01/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/07/2019
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kik Piedmont LLC078482780manufacture(0363-8897)
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