Label: LIDOCOLL- lidocaine hcl 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 December 29, 2011

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  • ACTIVE INGREDIENT

    Lidocaine HCl 4%...............Anesthetic

  • Purpose

    Anasthetic
  • Warning

    Keep out of reach of children

  • Use

    For the temporary relief of pain and
    itching associated with minor burns,
    sunburn, minor cuts, scrapes, insect
    bites or minor skin irritations.
  • Warning

    Avoid contact with eyes. If condition
    worsens, or if symptoms persist for
    more than 7 days or clear up and
    occur again within a few days,
    discontinue use and consult a doctor.
    Keep out of reach of children.

  • Directions

    Adults and children 2 years of age
    and older: Apply Lidocoll spray not
    more than 3 to 4 times per day or
    moisten dressing prior to removal
    to reduce pain.
    Children under 2 years of age
    consult a doctor.

  • Inactive Ingredients

    hydrolyzed fish collagen (15%),
    purified water, benzethonium
    chloride and HCl.

  • PRINCIPAL DISPLAY PANEL


    Bottle Front





  • INGREDIENTS AND APPEARANCE
    LIDOCOLL 
    lidocaine hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51715-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride4.6 g  in 115 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Benzethonium Chloride (UNII: PH41D05744) 115 mg  in 115 g
    Hydrochloric Acid (UNII: QTT17582CB) 100 mg  in 115 g
    Fish (UNII: 1PIO77PW2X) 17.25 g  in 115 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51715-001-01115 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2011
    Labeler - Innocoll Pharmaceuticals (989921395)
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