Label: ASPER FLEX- lidocaine cream

  • NDC Code(s): 71399-0049-1, 71399-0049-3, 71399-0049-5
  • Packager: Akron Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 3, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Lidocaine 4% w/w

  • Purpose

    Topical anesthetic

  • Uses

    temporarily relieves pain and itching due to

    • minor cuts
    • minor scrapes
    • minor burns
    • sunburn
    • minor skin irritation
    • 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
  • Directions

    • Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day.
    • Children under 2 years of age: Consult a doctor.
  • For external use only

    Do not use

    • in or near the eyes
    • in large quantities, particularly over raw or blistered areas

    Stop use and ask a doctor if

    • allergic reaction occurs
    • condition worsens or does not improve within 7 days
    • symptoms clear up and return within a few days
    • redness, irritation, swelling, pain or other symptoms begin or increase

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

  • Other information

    • May be applied under occlusive dressing.
    • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
  • Inactive ingredients

    Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Puried Water, Trolamine and Vitamin E Acetate.

  • Questions or comments?

    Call toll-free 1-877-255-6999

    Manufactured for:

    Akron Pharma Inc.

    Fairfield, Nj 07004

    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

    4-5-1

    4-5-2

    4-5-3

    4-5-4

    4-5-5

    4-5-6

  • INGREDIENTS AND APPEARANCE
    ASPER FLEX 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0049
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Product Characteristics
    Colorwhite (clear gel) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0049-51 in 1 CARTON11/03/2023
    15 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:71399-0049-11 in 1 CARTON11/03/2023
    215 g in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:71399-0049-31 in 1 CARTON11/03/2023
    330 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/03/2023
    Labeler - Akron Pharma Inc. (067878881)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!