Label: ZONE 2- lidocaine hcl, epinephrine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 3, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT


    Active Ingredients (in each cc)Purpose
    Lidocaine HCL5%Topical Anesthetic
    Epinephrine0.01%Vasoconstrictor
  • INDICATIONS & USAGE

    Uses: Temporarily relieves local pain and swelling on irritated hemorrhoidal tissue or other anorectal disorders.

  • WARNINGS

    WARNINGS: External use only.
    Do not swallow. Keep out of children's reach.

  • DO NOT USE

    Do not use if you have

    • A history of sever liver disease or impairment.
    • A known allergy or sensitivity to any of the components of this product. If sensitivity occurs, consult a doctor if condition worsens or does not improve in seven days, or clears up and occurs again within a few days. Do not use in large quantities, particularly over raw surfaces or blistered areas.

    Do not use if pregnant or nursing. In case of accidental contact with eyes, rinse immediately with copious amounts of eyewash. Seek care by an eye care physician. If accidentally swallowed, get medical help immediately.

  • When using this product

    • You may notice temporary blanching, skin irritation or sensitivity of the skin where gel is applied
    • You may not have pain - avoid sources of heat or injury
    • You may have delayed swelling after drug is dissipated
  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions:  Sensitivity test advised prior to use.

    Apply sparingly to affected area up to four times daily and cover with occlusive dressing. Product is ineffective when applied to intact skin. Wait until anesthetic effect occurs (2-5 minutes). Remove product.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified Water, Ethoxydiglycol, Propylene Glycol, Hydroxyethylcelluse, Sodium Metabisulfite, Diazolidinyl Urea, Disodium EDTA, Methyl Paraben, Propyl Paraben, and Citric Acid.

  • STORAGE AND HANDLING

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

  • QUESTIONS

    Questions? Contact distributor on product label for further questions.

  • PRINCIPAL DISPLAY PANEL

    NDC Code: 80069-012-01

    MAXIMUM
    Zone 2

    TOPICAL ANALGESIC


    1 oz.

    for use during a pain sensitive procedure

    Distributed by: DERMAL SOURCE
    Portland, OR 97232
    www.dermalsource.com
    1-866-568-3223

    label
  • INGREDIENTS AND APPEARANCE
    ZONE 2 
    lidocaine hcl, epinephrine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80069-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous50 mg  in 1 mL
    Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH) Epinephrine0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80069-012-0129.5735 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/202206/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01504/01/202206/24/2024
    Labeler - Dermal Source, Inc. (183535629)
    Establishment
    NameAddressID/FEIBusiness Operations
    HTO Nevada, Inc. (dba Kirkman)117115846manufacture(80069-012)