EXIGENCE ONE PATCH

Topical Analgesic

For external use only not intended for ingestion.

Do not use in large quantities, particularly over raw surfaces, or blistered areas.

Avoid contact with the eyes.

Stop use and ask doctor if 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 20-25 oC (68-77 oF) and protect from moisture.

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

Questions?

(310) 320-0100

Lidocaine 4%

Menthol 1%

EXIGENCE ONE PATCH
exigence one patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72189-296(NDC:81902-102)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72189-296-01	4 g in 1 PATCH; Type 0: Not a Combination Product	12/02/2021	12/02/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	12/02/2021	12/02/2022

Labeler - DirectRx (079254320)

Registrant - DirectRx (079254320)

Name	Address	ID/FEI	Business Operations
Establishment
DirectRx		079254320	repack(72189-296)

Revised: 10/2023

Document Id: 074b730e-ba75-c0de-e063-6294a90a964f

Set id: d22c67dd-b8e6-b8bd-e053-2995a90a2041

Version: 4

Effective Time: 20231009

DirectRx