Label: MG217COOLINGBURNSPRAY- lidocaine, benzalkonium chloride 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 January 13, 2022

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  • PURPOSE

    First aid to help prevent bacterial contamination or skin infections, and temporary relief of pain and itching associated with minor: cuts, scrapes, burns, sunburn, skin irritations.

  • Drug Facts

    Active ingredients

    Active ingredientsPurpose
    Benzalkonium Chloride 0.13%First aid antiseptic
    Lidocaine HCI USP 4%

    Pain reliever

  • Uses

    First aid to help prevent bacterial contamination or skin infections, and temporary relief of pain and itching associated with minor: cuts, scrapes, burns, sunburn, skin irritations.

  • Warnings

    For external use only.

    Ask a doctor before use if you have • deep puncture wounds • animal bites • serious burns

    When using this product • do not use in or near the eyes • do not apply over large areas of the body or in large quantities • do not apply over raw surfaces or blistered areas • avoid prolonged storage above 40C° (104°F)

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

    Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 2 years and older: clean the affected area, apply a small amount on the area 1 to 3 times daily. • may be covered with a sterile bandage • if bandaged, let dry first.

  • Other information

    • Do not puncture or incinerate • contents under pressure

  • Inactive ingredients

    Aloe barbadensis leaf extract (Aloe vera), Camphor, Deionized water, Propylene glycol

  • Questions or comments?

    1-800-635-3696

  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    MG217COOLINGBURNSPRAY 
    lidocaine, benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68093-7319
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.013 g  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68093-7319-1113 g in 1 CAN; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/17/2020
    Labeler - Wisconsin Pharmacal Company (800873986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company800873986manufacture(68093-7319) , pack(68093-7319) , label(68093-7319)
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