Label: SIMPLICITY DESENSITIZING- lidocaine gel

  • 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 July 15, 2014

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  • 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)
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