SIMPLICITY DESENSITIZING (LIDOCAINE) GEL [ SIMPLICITY LASER, LLC]

  • Home
  • SIMPLICITY DESENSITIZING (LIDOCAINE) GEL [ SIMPLICITY LASER, LLC]

SIMPLICITY DESENSITIZING (LIDOCAINE) GEL [ SIMPLICITY LASER, LLC]
PDF | XML
NDC 69109-004-30
Set ID 8660021c-69c4-49c3-959d-2182c581aa0f
Category HUMAN OTC DRUG LABEL
Packager Simplicity Laser, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
View All Sections
  • Active Ingredient:

    Lidocaine 4% w/w

  • Purpose


    Topical anesthetic

  • Use:

    temporarily relieves pain and itching due to:

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

    For external use only.

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

    Stop use and ask 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.

  • Directions:

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

    Store at USP controlled room temperature 20-25 deg.C (68-77 deg.F).

  • Inactive ingredients

    Ag,carbomer 940, deionized water

  • Simplicity Desensitizing Gel, 1 fl oz/30mL (69109-004-30)

    Label1

    Label2

  • INGREDIENTS AND APPEARANCE
    SIMPLICITY DESENSITIZING 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69109-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69109-004-3030 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/15/2014
    Labeler -  Simplicity Laser, LLC (079456595)
    Establishment
    NameAddressID/FEIBusiness Operations
    Results RNA, LLC078395000manufacture(69109-004)
View All Sections

Related Drugs

Search DailyMed Drugs