LIDOPATCH- lidocaine hcl, menthol patch

LidoPatch by

Drug Labeling and Warnings

LidoPatch by is a Otc medication manufactured, distributed, or labeled by JAR Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine HCL 3.6%

Menthol 1.25%

Purpose

Topical Analgesic

Topical Analgesic

INDICATIONS & USAGE

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

LidoPatch
contains lidocaine
PAIN RELIEF PATCH

For minor pain associated with
arthritis
back pain
muscle sprains & strains
The only over the counter patch with lidocaine
ultra thin, flexible, trim to fit

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.

Handling and Disposal

• hands should be washed after the handling and eye contact should be avoided
• do not store patch outside the sealed envelope
• apply immediately after removal from protected envelope
• fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get them
• kept out of the reach of children both before and after use

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 br east-feeding, ask a health professional before use.

Directions

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Dihydroxyaluminum Aminoscetate. Disodium EDTA, Glycerin, Methylparaben, Polysorbate 80, Polyvinyl alcohol, Propylene glycol, Propylparaben, Sodium, Carboxymethyl Cellulose, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOPATCH 
lidocaine hcl, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10882-528
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	505 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	175 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10882-528-01	1 in 1 BOX; Type 0: Not a Combination Product	10/29/2015
2	NDC: 10882-528-03	3 in 1 BOX; Type 0: Not a Combination Product	10/29/2015
3	NDC: 10882-528-30	30 in 1 BOX; Type 0: Not a Combination Product	10/29/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/29/2015

Labeler - JAR Laboratories (968952239)

Establishment
Name	Address	ID/FEI	Business Operations
Bingbing Pharmaceutical (Hubei) Co., Ltd		554413454	manufacture(10882-528)

Establishment
Name	Address	ID/FEI	Business Operations
INTERMED		676244169	manufacture(10882-528)