Label: BURN RELIEFPREFERRED PLUS PH PREFERRED PLUS PHARMACY- lidocaine hcl gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 15, 2013

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  • ACTIVE INGREDIENT

    Lidocaine HCl 0.50%

  • INDICATIONS & USAGE

    Uses

    Temporarily relief of pain and itching due to:  sunburn, minor burns, insect bites, cuts, and scrapes.

  • WARNINGS

    Warnings

    For external use only.  Avoid contact with eyes.  If symptoms persist for more than 7 days, discontinue use and consult a physician.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older:  apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age:  consult a physician.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Vera Gel, Water, Propylene Glycol, Glycerin, Triethanolamine, Isopropyl Alcohol, Polysorbate, Carbomer, Diazolidinyl Urea, Menthol, Disodium EDTA, Yellow 5, Blue 1.

  • PURPOSE

    Purpose

    Pain Reliever.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    Preferred Plus Pharmacy Burn Relief Aloe Gel with Lidocaine.

    Label image

  • INGREDIENTS AND APPEARANCE
    BURN RELIEFPREFERRED PLUS PH  PREFERRED PLUS PHARMACY
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe (UNII: V5VD430YW9)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Menthol (UNII: L7T10EIP3A)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-022-08237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34803/15/2013
    Labeler - Kinray Inc. (012574513)
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