ZYLOTROL MAXIMUM PAIN LIDOCAINE 4% MENTHOL 1% WHITESTONE PRODUCTS LLC FDA Approved Uses For the temporary relief of pain.
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Substance Lidocaine
Route
TOPICAL
Applications
505G(A)(3)
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Lidocaine 4% w/w Menthol 1% w/w
Inactive Ingredients
Inactive Ingredients Water Glycerin Polyacrylic Acid Propylene Glycol Sodium Polyacrylate Polysorbate 80 Mineral oil Polyvinylpyrrolidone K90 Hydroxyacetophenone L(+)-Tartaric Acid Dihydroxyaluminium Aminoacetate Edetate Disodium Kaolin Titanium Dioxide
Strengths
4 % 1 %
Treats Conditions
Uses For The Temporary Relief Of Pain
Pill Appearance
Color: brown

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
98PI200987 L7T10EIP3A
Packaging

Principal Display Panel label

Package Descriptions
  • Principal Display Panel label

Overview

Uses For the temporary relief of pain.

Indications & Usage

Uses For the temporary relief of pain.

Dosage & Administration

Directions Adult and children 12 years of age and over: Clean and dry affected area Remove film from patch and apply to the skin (see illustration) Apply 1 patch at a time to affected area, not more than 3 to 4 times daily Remove patch from the skin after at most 8-hour application Children under 12 years of age: Consult a doctor

Warnings & Precautions
Warnings For external use only
Purpose

Purposes Topical analgesic Topical analgesic

Do Not Use

Do not use: More than 1 patch at a time On wounds or damaged skin For more than one week without consulting a doctor 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 & Ask a Doctor

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

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

Storage & Handling

Other information Store at 68-77℉ (20-25℃) Store in a cool dry place away from direct sunlight

Questions

Questions? (310) 320-0100


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