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PAIN RELIEF by ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD

Medically reviewed on Jan 8, 2018

Dosage form: patch
Ingredients: LIDOCAINE 4g in 100g, METHYL SALICYLATE 4g in 100g, MENTHOL 5g in 100g
Labeler: ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD
NDC Code: 70355-001

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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. 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 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)

PAIN RELIEF 
lidocaine hydrochloride,menthol,methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70355-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE4 g  in 100 g
MENTHOL (MENTHOL) MENTHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
TALC 
TARTARIC ACID 
STARCH, CORN 
SORBITAN SESQUIOLEATE 
ACRYLIC ACID 
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
2-ETHYLHEXYL ACRYLATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
SODIUM POLYACRYLATE (2500000 MW) 
NONOXYNOL-30 
POLYACRYLIC ACID (8000 MW) 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:70355-001-0915 POUCH in 1 BOX
13 PATCH in 1 POUCH
10.408 g in 1 PATCH
2NDC:70355-001-1015 POUCH in 1 BOX
25 PATCH in 1 POUCH
20.408 g in 1 PATCH
3NDC:70355-001-116 POUCH in 1 BOX
33 PATCH in 1 POUCH
30.408 g in 1 PATCH
4NDC:70355-001-124 POUCH in 1 BOX
41 PATCH in 1 POUCH
40.408 g in 1 PATCH
5NDC:70355-001-1324 POUCH in 1 BOX
52 PATCH in 1 POUCH
50.85 g in 1 PATCH
6NDC:70355-001-1424 POUCH in 1 BOX
64 PATCH in 1 POUCH
60.408 g in 1 PATCH
7NDC:70355-001-1524 POUCH in 1 BOX
75 PATCH in 1 POUCH
70.408 g in 1 PATCH
8NDC:70355-001-1624 POUCH in 1 BOX
86 PATCH in 1 POUCH
80.408 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/30/2015
Labeler - ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD (546989657)
Establishment
NameAddressID/FEIOperations
ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD546989657manufacture(70355-001)

 
ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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