Label: LIDOCAINE DRY- lidocaine 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 August 4, 2021

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  • Active Ingredient

    Lidocaine 4%

  • Topical Anesthetic

  • Use

    temporarily relieves minor pain

  • Warnings

    For external use only

  • Do not use

    • On large areas of the body or on cut, irritated or swollen skin.
    • On puncture wounds
    • for more than one week without consulting a doctor
  • When using this product

    • Use only as directed. Read and follow all directions and warnings on this label
    • do not allow contact with the eyes and mucous membranes
    • avoid spraying on face
    • avoid inhalation of spray
    • do not bandage or apply local heatl(such as heating pads) or a medicated patch to area of use
    • do not use at the same time as other topical analgesics
  • Stop use and as a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms perisist for more than 7 days or clear up and occur again within a few days.
  • Extremely Flammable

    • do not use near heat or flame or while smoking
    • avoid long term storage above 104°F (40°C)
    • do not puncture or incinerate. Contents under pressure.
    • do not store at temperatures above 120°F (49°C)
  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children over 12 years:

    • spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
    • product will dry quickly on its own, and does not need to be rubbed in

    children 12 years or younger: ask a doctor

  • Inactive Ingredients

    caprylic/capric triglyceride, isobutane, propylene glycol, alcohol 40B (30%)

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE DRY 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-543
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-543-04113 mL in 1 CAN; Type 0: Not a Combination Product07/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/22/2021
    Labeler - CVS (062312574)
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