NDC 81902-303 Zylotrol-l

Lidocaine 4%, Isopropyl Alcohol

NDC Product Code 81902-303

NDC 81902-303-15

Package Description: 1 KIT in 1 CARTON * 5 g in 1 POUCH * 1 mL in 1 PACKET

NDC Product Information

Zylotrol-l with NDC 81902-303 is a a human over the counter drug product labeled by Whitestone Products Llc. The generic name of Zylotrol-l is lidocaine 4%, isopropyl alcohol. The product's dosage form is kit and is administered via topical form.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FLAX SEED (UNII: 4110YT348C)
  • ACRYLIC ACID (UNII: J94PBK7X8S)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Whitestone Products Llc
Labeler Code: 81902
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-27-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Zylotrol-l Product Label Images

Zylotrol-l Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

First Aid Antiseptic

Uses

For the temporary relief of pain

Warnings

For external use only

  • For external use only Flammable, keep away from fire or flame

Otc - Do Not Use

  • Do not use:More than 1 patch at a timeOn wounds or damaged skinWith a heating padIf you are allergic to any ingredients of this product

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

Otc - When Using

  • When using this product:Use only as directedAvoid contact with the eyes, mucous membranes, or rashesDo not bandage tightly

Otc - Stop Use

  • Stop use and ask a doctor if:Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blisteringConditions worsenSymptoms persist for more than 7 daysSymptoms clear up and occur again within a few days

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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

  • Keep out from 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 areaOpen pouch and remove one patchApply 1 patch at a time to affected area; not more than 3 to 4 times dailyReseal pouch containing unused patches after each useRemove patch from the skin after at most 8-hour applicationChildren under 12 years of age:Consult a doctor

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

Other Information

  • Avoid storing product in direct sunlightProtect product from excessive moisture

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

Other Ingredients

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Other

Questions or comments? 866-747-7365

Active Ingredient

Isopropyl Alcohol 70% v/v

Use

For preparation of the skin prior to an injection

Inactive Ingredients

Purified water

* Please review the disclaimer below.