LIDOPATCH- lidocaine, menthol patch

Lidopatch by

Drug Labeling and Warnings

Lidopatch by is a Otc medication manufactured, distributed, or labeled by J.A.R. Laboratories, Bingbing Pharmaceutical (Hubei) Co., Ltd, INTERMED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

WARNINGS SECTION
For external use only. Do not use if you are allergic or sensitive to lidocaine or menhol. Do not use if pouch is damaged or opened.

PURPOSE

PURPOSE

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

ACTIVE INGREDIENT

ACTIVE INGREDIENT SECTION
Lidocaine HCL 3.6% - Topical analgesic
Menthol 1.25% - Topical analgesic

STOP USE

STOP USE SECTION
Stop Use and ask doctor if:
excessive redness or irritation is present
Pain persists for more than 7 days
symptoms cear up and occur again within a few days
conditions worsens
If pregnant or breasfeading, 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.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions: Aduts 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 INGREDIENT

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum aminoacetate, Disodium EDTA, Glycerine, Methylparaben, Polysorbate 80, Polyvinyl alcohol, Propylene glycol, Propyl paraben, Sodium, Carboxymethylcellulose, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, Water

INDICATIONS & USAGE

Usage
Aduts apply patch to affected area for a maximum of 12 hours.
Do not use more than 1 patch every 24 hours

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

LIDOPATCH 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10882-527
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.036 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.0125 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYLPARABEN (UNII: A2I8C7HI9T)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10882-527-01	1 in 1 PACKAGE; Type 0: Not a Combination Product	03/02/2016
2	NDC: 10882-527-02	30 in 1 PACKAGE; Type 0: Not a Combination Product	03/02/2016
3	NDC: 10882-527-04	30 in 1 PACKAGE; Type 0: Not a Combination Product	03/02/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/02/2016

Labeler - J.A.R. Laboratories (968952239)

Establishment
Name	Address	ID/FEI	Business Operations
Bingbing Pharmaceutical (Hubei) Co., Ltd		554413454	manufacture(10882-527)

Establishment
Name	Address	ID/FEI	Business Operations
INTERMED		676244169	manufacture(10882-527)