Label: LEVIGOSP- lidocaine/benzalkoium chloride spray 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 February 14, 2018

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  • Description

    LevigoSP is a Lidocaine HCL 2.5% and Benzalkonium Chloride 0.13% topical anesthetic and antiseptic spray indicated to temporarily relieve minor pain.

  • Active Ingredients

    Lidocaine HCL 2.5% --- Pain Reliever

    Benzalkonium Chloride 0.13% --- First Aid Antiseptic

  • Purpose

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

  • Warnings

    For external use only.

  • Ask Doctor

    Ask a doctor before use if you have: *deep or puncture wounds *animal bites *serious burns.

  • When Using This Product

    When using this product: *use only as directed *do not use in or near the eyes *do not apply over large areas of the body *do not apply over raw surfaces or blistered areas.

  • Stop Use

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Indications & Usage

    Directions:

    Adults and Children over 2 years: Clean the affected area, apply a small amount on the affected area 1 to 3 times daily. If bandaged, let dry first.

    Children under 2 years: Ask a doctor.

    Pregnant or breast feeding: Ask a doctor.

  • Dose & Aministration

    Manufactured By:

    Wisconsin Pharmacal Co.

    1 Pharmacal Way

    Jackson, WI 53037

    Made in the U.S.A. of U.S. and imported materials.

    Net Wt. 8 FL OZ (240mL) bottle

  • Questions or Comments

    For questions or comments, call 1-800-635-3696.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Camphor, Deionized water, Propylene Glycol

  • Storage & Handling

    Protect from excessive heat.

  • Package Label. Principal Display Panel

    Package Label

  • INGREDIENTS AND APPEARANCE
    LEVIGOSP 
    lidocaine/benzalkoium chloride spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70112-155
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 mg  in 1 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70112-155-08240 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2018
    Labeler - Topicare Management, LLC (079902303)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topicare Management, LLC079902303label(70112-155)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company, LLC800873986manufacture(70112-155)
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