Label: WALGREENS PAIN BURN ITCH RELIEF- benzocaine 20%, menthol 0.5% spray

  • 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 June 29, 2022

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  • ACTIVE INGREDIENT

    20% Benzocaine

    0.5% Menthol

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    For temporary relief of pain and itching associated with :

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

    For External use only

    Flamable:

    • Do not use near heat, flame, or fire or while smoking

    Allergy Alert:

    • Do not use this product if you have a history of allergy to local anesthetics such as procaine, benzocaine or other "caine" anesthetics.

    Avoid contact with eyes. Do not spray in the face or mouth

    Use only as ditected

    Intentional misuse by delibrately concentrating or inhailing the contents can be harmful or fatal

    Do not puncture or incinerate.Contents under pressure. Do not store at temperatures above 120°F.

  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • itiching, rash or irritation develops
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poision Control Center right away. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older : Apply to the affected area not more than 3 to 4 times daily

    Children under 2 years of age: Cinsult a doctor

    • To use this product, hold the can 6 to 12 inches away from the affected area. Direct spray nozzle towards skin and press button to activate spray.
    • To apply to face, spray in palm of hand and gently apply.
  • OTHER SAFETY INFORMATION

    • Avoid contact with leather, fabric and upholstery to prevent possible staining or discoloration
    • Store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Aloe Vera, Phenoxyethanol, Polyethylene Glycol 400, Tetrafluoroethane

  • QUESTIONS

    1-800-925-4733

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    WALGREENS PAIN BURN ITCH RELIEF 
    benzocaine 20%, menthol 0.5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 1 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    NORFLURANE (UNII: DH9E53K1Y8)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2053-0278 g in 1 CAN; Type 0: Not a Combination Product05/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/05/2022
    Labeler - Walgreens (008965063)
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