Zylotrol for Pain Control Lidocaine 4% and Menthol 4%

Zylotrol by

Drug Labeling and Warnings

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

Drug Details [pdf]

ZYLOTROL- lidocaine 4%, menthol 4% patch 
Whitestone Products LLC

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Zylotrol for Pain Control Lidocaine 4% and Menthol 4%

Active ingredients

Lidocaine 4%

Menthol 4%

Purpose
Analgesic
Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• muscle strains
• sprains
• bruises
• muscle soreness
• muscle stiffness

Warnings: For external use only. Keep out of reach of children. Packaging is not child resistant. If put in mouth, contact a Poison Control Center right away. Use only as directed. Read and follow all directions and warnings on this box.

Do not use:

• near the eyes and mucous membranes
• on open wounds, cuts, damaged or infected skin
• at the same time as other topical analgesics
• with a heating pad
• on genitals
• if patch pouch has been opened for 7 or more days

Before use, ask a doctor if:

• you are allergic to any of the listed ingredients
• you are pregnant or breastfeeding
• you have high blood pressure, heart disease or kidney disease
• you are taking a diuretic

When using patches:

• wash hands thoroughly after applying or removing patch
• avoid contact with eyes. If eye contact occurs, rinse thoroughly with water

Stop use and ask a doctor if:

• condition worsens
• rash, irritation or itching develops
• symptoms persist for more than 7 days or clear up and occur again within a few days.

If swallowed, get medical help, or contact a Poison Control Central right away.

Directions: Adults 18 years and older - apply patch to affected area 1 to 2 times daily or as directed by your physician. Clean and dry affected area. Open pouch, remove one patch and remove protective film. Apply to affected area and leave in place for 8 to 12 hours. Only use one patch at a time. Do not use more than 2 patches per day. Reseal pouch containing unused patches after each use. Not indicated for children under 18 years of age.

Avoid storing product in direct sunlight. Protect contents from excessive moisture. Store at 66 - 77°F (19 - 25°C)

Inctive ingredients

Acrylic adhesive

Questions: (310) 320-0100

ZYLOTROL 
lidocaine 4%, menthol 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81902-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81902-130-15	15 in 1 BOX	09/26/2022	10/04/2023
1		4 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/26/2022	10/04/2023

Labeler - Whitestone Products LLC (118064415)

Revised: 10/2023

Document Id: 06f12d50-ad66-e3ff-e063-6294a90abdb9

34390-5

Set id: 8f60e1a8-ed1f-4b4c-802b-8806951811fa

Version: 2

Effective Time: 20231005