Label: CVSLIDOCAINEANTISEPTICSPRAY- lidocaine and 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

    Temporarily relieves pain and itching due to: sunburn,minor burns,minor cuts,scrapes, insect bites,minor skin irritations,First aid to help kill germs.

  • Drug Facts

    Active ingredients

    Active ingredientsPurposes
    Benzalkonium Chloride 0.13% (w/w)First Aid Antiseptic
    Lidocaine HCl 4.0% (w/w)External Analgesic

  • Uses

    ■ Temporarily relieves pain and itching due to: ■ sunburn ■ minor burns ■ minor cuts
    ■ scrapes ■ insect bites ■ minor skin irritations ■ First aid to help kill germs

  • 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 ■ use only as directed

    Stop use and ask 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 immediately.

  • 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 ■ to apply to face, spray into palm of hand and gently apply

  • Other information

    Keep cap tightly closed when not in use. Contents under pressure. Do not puncture or incinerate. Store at temperatures between 45ºF-130ºF (7º-54ºC). Avoid excessive heat.

  • Inactive ingredients

    Camphor, Deionized Water, Propylene Glycol, Sodium Hydroxide

  • Questions or comments?

    1-800-635-3696

  • Principal Display Panel

    CVS

    Health ™

    MAXIMUM STRENGTH

    Lidocaine
    Antiseptic
    Spray

    BENZALKONIUM Cl 0.13%
    LIDOCAINE HCl 4%

    First aid antiseptic
    Pain reliever

    SPRAYS

    ANY ANGLE

    Soothing infection
    protection

    • Relieves pain

    on contact

    • Kills germs

    NET WT 4 OZ (113 g)

    image

  • INGREDIENTS AND APPEARANCE
    CVSLIDOCAINEANTISEPTICSPRAY 
    lidocaine and benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-710
    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)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-710-01113 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 - CVS Health (062312574)
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