Label: ZYLOTROL-L- lidocaine 4%, isopropyl alcohol kit

  • NDC Code(s): 81902-303-15
  • Packager: Whitestone Products LLC
  • 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 October 27, 2021

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

  • Lidocaine 4% Patch

  • Active Ingredients

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Uses

    For the temporary relief of pain

  • Warnings

    For external use only

  • DO NOT USE

    Do not use:

    • More than 1 patch at a time
    • On wounds or damaged skin
    • With a heating pad
    • If you are allergic to any ingredients of this product
  • WHEN USING

    When using this product:

    • Use only as directed
    • Avoid contact with the eyes, mucous membranes, or rashes
    • Do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if:

    • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • Conditions worsen
    • Symptoms persist for more than 7 days
    • Symptoms clear up and occur again within a few days
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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.

  • Directions

    Adults and children 12 years of age or over:

    • Clean and dry the affected area
    • Open pouch and remove one patch
    • Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
    • Reseal pouch containing unused patches after each use
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age:

    • Consult a doctor
  • Other Information

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture

  • Other Ingredients

    Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

  • SPL UNCLASSIFIED SECTION

    Questions or comments? 866-747-7365

  • Isopropyl Alcohol 70% Prep Pads

  • Active ingredient

    Isopropyl Alcohol 70% v/v

  • Purpose

    First Aid Antiseptic

  • Use

    For preparation of the skin prior to an injection

  • Warnings

    • For external use only
    • Flammable, keep away from fire or flame
  • DO NOT USE

    • Do not use with electrocautery procedures
    • Do not use in the eyes
    • Do not apply to irritated skin

    • Stop use if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.

    • Keep out from reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Open packet
    • Remove pad
    • Apply topically as needed to cleanse intended area. Discard after single use.
  • Other information

    • Store at room temperature 59-86°F (15-30°C)
    • Contents sterile in unopened, undamaged package
  • Inactive ingredients

    purified water

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    NDC: 81902-303-15

    Zylotrol TM-L

    Pacakge Contains:

    15 Lidocaine 4% Patches

    15 Isopropyl Alcohol 70% Prep Pads

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ZYLOTROL-L 
    lidocaine 4%, isopropyl alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81902-303
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81902-303-151 in 1 CARTON; Type 1: Convenience Kit of Co-Package10/27/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 POUCH 15 g
    Part 215 PACKET 15 mL
    Part 1 of 2
    LIDOCAINE 4% 
    lidocaine 4% patch
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    FLAX SEED (UNII: 4110YT348C)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/24/2021
    Part 2 of 2
    ISOPROPYL ALCOHOL 
    isopropyl alcohol swab
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/09/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/27/2021
    Labeler - Whitestone Products LLC (118064415)