Label: LIDOCAINE ointment

  • 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 April 3, 2023

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  • Active ingredient

    Lidocaine HCL 4%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor pain & itching due to:

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

    For external use only

  • DO NOT USE

    Do not use

    • if you are allergice to any active or inactive ingredients of this product
    • on wonds or damaged, irritated, or sensitive skin
    • with any other topical anesthetic
    • for more than one week without constulting a doctor
    • over large areas of the body
  • WHEN USING

    When using this product

    • do not use in or near the eyes
    • do not use in large quantities, particularly over raw surfaces or blistered areas
  • STOP USE

    Stop use and ask a doctor if

    • symptoms presist for more than seven days or clear up and occur again within a few days
    • Condition worsens
    • localized skin reactions occur such as rash, pain, itching, readness, irritation, swelling or blistering
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets. If chewed or swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
    • Children under 2 years: Consult a doctor.
  • Other information

    • for topical use only
    • do not use in the eyes
    • Store are room temperature 15°-30°C (59°-86°F)
  • Inactive ingredients

    aloe vera, mineral oil, petrolatum white, phenoxyethanol, polysorbate 80, purified water.

  • Questions or comments?

    Call toll-free 1-877-255-6999

    Childproof Packaging

    Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

    Manufactured for:

    Akron Pharma Inc.

    Fairfield, Nj 07004

    Visit at: www.akronpharma.com

  • Drug Facts

  • PRINCIPAL DISPLAY PANEL

    Maximun Strength

    NDC 71399-6544-1

    AsperFlex™

    Touch on Pain

    Lidocaine 4% Ointment

    Pain reliving Formula

    Topical Analgesic

    Numbs Away Pain

    Made in the USA

    NET WT 3.53 OZ (100g)

    Lidocaine label

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-6544
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    Product Characteristics
    Colorwhite (clear gel) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-6544-11 in 1 JAR; Type 0: Not a Combination Product11/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2021
    Labeler - Akron Pharma Inc. (067878881)
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