ZYLOTROL MAXIMUM PAIN PATCH- lidocaine 4%, menthol 1% patch
ASCLEMED USA INC.

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Zylotrol for Pain Control Lidocaine 4% and Menthol 1%

Lidocaine 4%

Menthol 1%

Topical Analgesic

For external use only not intended for ingestion.

in large quantities, particularly over raw surfaces, or blistered areas.

Avoid contact with eyes.

condition worsens, or if symtoms 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.

ask a health professional before use.

DIRECTIONS

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily.
Children under 2 years of age: consult a doctor.

Store at 20-25oC (68-77oF) and protect from moisture.

polyacrylamide, vinol, sodium polyacrylate; acrylate polymerization; purified water.

Questions?

(310) 320-0100

USES

For the temporary relief of pain.

box

ZYLOTROL MAXIMUM PAIN PATCH
lidocaine 4%, menthol 1% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76420-144(NDC:81902-101)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ETHENYL (UNII: PQ2K3G3591)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76420-144-15	15 in 1 BOX	08/20/2021
1		4 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	07/30/2021

Labeler - ASCLEMED USA INC. (059888437)

Name	Address	ID/FEI	Business Operations
Establishment
ASCLEMED USA INC. DBA ENOVACHEM		059888437	relabel(76420-144)

Revised: 10/2023

Document Id: 0831f4f6-1154-c740-e063-6294a90a33ef

Set id: 38a417a6-688e-40c7-965d-5791203f4133

Version: 2

Effective Time: 20231020

ASCLEMED USA INC.