Zylotrol-L by Whitestone Products LLC Zylotrol-L

Zylotrol-L by

Drug Labeling and Warnings

Zylotrol-L by is a Otc medication manufactured, distributed, or labeled by Whitestone Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZYLOTROL-L- lidocaine 4%, isopropyl alcohol 
Whitestone Products LLC

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.

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Zylotrol-L

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:

  • 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 this product:

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

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

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

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

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 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

NDC: 81902-303-15

Zylotrol TM-L

Pacakge Contains:

15 Lidocaine 4% Patches

15 Isopropyl Alcohol 70% Prep Pads

Principal Display Panel

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-Package10/27/202108/31/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 POUCH 15 g
Part 215 PACKET 15 mL
Part 1 of 2
LIDOCAINE 4% PATCH 
lidocaine 4% patch
Product Information
Item Code (Source)NDC: 70512-014
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)  
Product Characteristics
Color    Score    
ShapeRECTANGLE (White Flexible Patch) Size
FlavorImprint Code
Contains    
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 finalpart34805/24/202105/24/2021
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 finalpart34810/27/202108/31/2023
Labeler - Whitestone Products LLC (118064415)

Revised: 10/2022
Document Id: eafae824-10d8-2b3f-e053-2a95a90acc81
Set id: 2106893c-d736-421d-b038-cfedd12fe21b
Version: 2
Effective Time: 20221014