ZYLOTROL MAXIMUM PAIN- lidocaine 4%, menthol 1% patch 
Whitestone Products LLC

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ZYLOTROL MAXIMUM PAIN PATCH

Active Ingredients

Lidocaine 4% w/w

Menthol 1% w/w

Purposes

Topical analgesic

Topical analgesic

Uses

For the temporary relief of pain.

Warnings

For external use only

Do not use:

When using this product:

Stop use and ask a doctor if:

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

Adult and children 12 years of age and over:

Children under 12 years of age: Consult a doctor

Other information

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

Questions?

(310) 320-0100

 Principal Display Panel

label

ZYLOTROL MAXIMUM PAIN 
lidocaine 4%, menthol 1% patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81902-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.03 g  in 3 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.12 g  in 3 g
Inactive Ingredients
Ingredient NameStrength
KAOLIN (UNII: 24H4NWX5CO)  
TARTARIC ACID (UNII: W4888I119H)  
WATER (UNII: 059QF0KO0R)  
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81902-104-1515 in 1 BOX12/23/2022
13 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)12/23/2022
Labeler - Whitestone Products LLC (118064415)

Revised: 10/2023
Document Id: 08157e80-effb-147b-e063-6394a90aca36
Set id: a80efad7-1d8b-4d8b-8c97-373174ce89ca
Version: 2
Effective Time: 20231021
 
Whitestone Products LLC