Label: ZONE 1- lidocaine hcl cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 1, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT


    Active Ingredients (in each cc)Purpose
    Lidocaine HCl 4%Topical Anesthetic
  • INDICATIONS & USAGE

    Indications: Temporarily relieves pain associated with anorectal disorders.

  • WARNINGS

    Warnings: Do not swallow. Keep out of children's reach.
    External use only on intact skin.

  • DO NOT USE

    Do not use if pregnant or breast-feeding.
    Do not use if you have seizures or liver disease.
    Do not use if you have a known allergy or sensitivity to any
    component of this product. If sensitivity occurs, discontinue
    use, immediately cleanse skin and seek medical attention. If
    condition worsens or if symptoms persist for more than seven
    days or clear up and occur again, discontinue use and consult
    a doctor. Do not use in large quantities, particularly over raw
    surfaces or blistered areas. Avoid contact with eyes. In case of
    contact with eyes, rinse immediately with copious amounts of
    eyewash and seek treatment by a medical professional. If
    accidentally swallowed, get medical attention immediately.

  • WHEN USING

  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions:  Sensitivity test advised prior to use.

    Apply a moderately thick layer of cream to intact skin. Discontinue use if
    sensitivity occurs. Wait for numbness to develop. For thinner skin (eye
    area) wait 10-15 minutes. For thicker skin, best results are obtained
    after 1 hour of application. Cleanse area thoroughly before procedure.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified Water, Glyceryl Stearate
    (and) PEG 100-Stearate, Petrolatum, Stearic Acid, Cetyl
    Alcohol, Xanthan Gum, Glycerol Monostearate, Sodium
    Hydroxymethlyglycinate, Triethanolamine, Propyl
    Paraben, Methyl Paraben, and BHT.

  • STORAGE AND HANDLING

    Other information: Store in a cool dark place or
    refrigerate. Discard by expiration date.

  • QUESTIONS

    Questions? Contact distributor on product label for further questions.

  • PRINCIPAL DISPLAY PANEL

    MAXIMUM

    Zone 1

    TOPICAL ANALGESIC

    7 pH

    1/2 oz.

    4% Lidocaine Cream

    for use before a
    pain sensitive procedure


    Distributed by: DERMAL SOURCE
    Portland, OR 97232

    www.dermalsource.com
    1-866-568-3223

    NDC 80069-014-01

    label
  • INGREDIENTS AND APPEARANCE
    ZONE 1 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80069-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Peg-100 Stearate (UNII: YD01N1999R)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium Hydroxymethylglycinate (UNII: DIG6BWZ9XT)  
    Trolamine (UNII: 9O3K93S3TK)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80069-014-0114.1748 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01511/01/2004
    Labeler - Dermal Source, Inc. (183535629)
    Establishment
    NameAddressID/FEIBusiness Operations
    HTO Nevada, Inc. (dba Kirkman)117115846manufacture(80069-014)