PAIN RELIEF- lidocaine hydrochloride,menthol,methyl salicylate patch

PAIN RELIEF by

Drug Labeling and Warnings

PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4% ………………………………………………………………………………………………Topical Anesthetic

Menthol 5% …………………………………………………………………………………………… Topical Analgesic

Methyl Salicylate 4% ………………………………………………………………………………… Topical Analgesic

Purpose

Topical Anesthetic

Use

Temporarily relieves aches and pains of muscles and joints associated

with: ·arthritis ·simple backache ·sprains ·strains ·muscle soreness

WARNINGS

Warnings

For external use only

Do not use ·on the face or rashes·on open wounds, cuts, damaged or infected skin ·with a heating pad ·if allergic to any ingredients · if condition worsens or symptoms persist for more than 7 days ·excessive skin irritation occurs

Ask a doctor before use if: .you are allergic to any ingredients ·you have high blood pressure,heart disease,or kidney disease ·you are pregnant

When using this product: avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.

If pregnant or breast-feeding, ask a health professional before use.

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.Package not child resistant.Dispose of the used patches by folding sticky ends together.

Directions

Adults and children over 12years: ·Carefully remove protective film from patch ·Apply one patch to affected area ·Repeat as necessary,but no more than 4 times daily.

Children under 12 years of age: Ask a doctor

Inactive Ingredients

Inactive Ingredients:

Acrulic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxy-nol-30, Polyacrylic Acid, Polysorbate 80, Sodium Polyacrylate, Sorbitan Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Diocide, Water

OTHER SAFETY INFORMATION

Other information

.some individuals may not experience pain relief until several minutes or hours after applying the patch

avoid storing product in direct sunlight .protect product from excessive moisture .store at 67-77°F (19-25°C)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF 
lidocaine hydrochloride,menthol,methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70355-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
STARCH, CORN (UNII: O8232NY3SJ)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70355-001-09	15 in 1 BOX
1		3 in 1 POUCH
1		0.408 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 70355-001-10	15 in 1 BOX
2		5 in 1 POUCH
2		0.408 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 70355-001-11	6 in 1 BOX
3		3 in 1 POUCH
3		0.408 g in 1 PATCH; Type 0: Not a Combination Product
4	NDC: 70355-001-12	4 in 1 BOX
4		1 in 1 POUCH
4		0.408 g in 1 PATCH; Type 0: Not a Combination Product
5	NDC: 70355-001-13	24 in 1 BOX
5		2 in 1 POUCH
5		0.85 g in 1 PATCH; Type 0: Not a Combination Product
6	NDC: 70355-001-14	24 in 1 BOX
6		4 in 1 POUCH
6		0.408 g in 1 PATCH; Type 0: Not a Combination Product
7	NDC: 70355-001-15	24 in 1 BOX
7		5 in 1 POUCH
7		0.408 g in 1 PATCH; Type 0: Not a Combination Product
8	NDC: 70355-001-16	24 in 1 BOX
8		6 in 1 POUCH
8		0.408 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/30/2015

Labeler - ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD (546989657)

Establishment
Name	Address	ID/FEI	Business Operations
ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD		546989657	manufacture(70355-001)