Zylotrol by Direct_Rx Zylotrol

Zylotrol by

Drug Labeling and Warnings

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

Drug Details [pdf]

ZYLOTROL- zylotrol patch 
Direct_Rx

----------

Zylotrol

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.

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.

(310) 320-0100

For the temporary relief of pain.

ZYLOTROL 
zylotrol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72189-474(NDC: 81902-101)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72189-474-15	4 g in 1 BOX; Type 0: Not a Combination Product	05/22/2023	10/09/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/22/2023	10/09/2023

Labeler - Direct_Rx (079254320)

Registrant - Direct_Rx (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
Direct_Rx		079254320	relabel(72189-474)

Revised: 9/2024

Document Id: 22548c98-a632-963d-e063-6294a90a41cb

34390-5

Set id: fc4e0263-3fba-fcb3-e053-6394a90a948c

Version: 4

Effective Time: 20240917