LIDOPATCH PAIN RELIEF- lidocaine and menthol patch

LidoPatch by

Drug Labeling and Warnings

LidoPatch by is a Otc medication manufactured, distributed, or labeled by 3T Federal Solutions LLC, Katecho. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Lidocaine 3.99%	Topical analgesic
Menthol 1%	Topical analgesic

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Warnings

For external use only.

Do not use if you are allergic or sensitive to lidocaine or menthol. Do not use if pouch is damaged or opened.

When using this product

• ❏ use only as directed
• ❏ avoid contact with eyes or mucous membranes
• ❏ do not apply to open wounds or sensitive skin
• ❏ do not bandage tightly or use a heating pad

Stop use and ask a doctor if

• ❏ excessive redness or irritation is present
• ❏ condition worsens
• ❏ pain persists for more than 7 days
• ❏ symptoms clear up and occur again within a few days

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

• ❏ adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
• ❏ children: consult your physician
• ❏ remove protective film, gently apply to affected area.

Inactive Ingredients

Glycerol, Water, Acrylamide/acrylate co-polymer, (Poly) vinyl pyrrolidone, Germaben II

Questions?

Email info@lidopatch.com

SPL UNCLASSIFIED SECTION

MFG by JAR Laboratories, Elmhurst, IL 60126

PRINCIPAL DISPLAY PANEL - 3 Topical Patch Carton

NDC 50682 527 03

GET PAIN
RELIEF NOW!

LidoPatch®

CONTAINS LIDOCAINE
PAIN
RELIEF
PATCH

• ✔ SAME ACTIVE INGREDIENT AS
  LEADING PRESCRIPTION PATCH
• ✔ ONE PATCH FOR 24 HOUR PAIN RELIEF
• ✔ FOR RELIEF OF LOCALIZED PAIN
• ✔ FAST ACTING
• ✔ ULTRA THIN, FLEXIBLE, TRIM TO FIT

3 TOPICAL PATCHES PER BOX

INGREDIENTS AND APPEARANCE

LIDOPATCH  PAIN RELIEF
lidocaine and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50682-527
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987)	lidocaine	40 mg
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A)	menthol	50 mg

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Acrylamide (UNII: 20R035KLCI)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Urea (UNII: 8W8T17847W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50682-527-03	3 in 1 CARTON
1		1 in 1 POUCH
2	NDC: 50682-527-07	7 in 1 CARTON
2		1 in 1 POUCH
3	NDC: 50682-527-30	30 in 1 CARTON
3		1 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	02/01/2012

Labeler - 3T Federal Solutions LLC (557502155)

Establishment
Name	Address	ID/FEI	Business Operations
Katecho		139791743	MANUFACTURE