Active Ingredient
Lidocaine 4% ………………………………………………………………………………………………Topical Anesthetic
Menthol 5% …………………………………………………………………………………………… Topical Analgesic
Methyl Salicylate 4% ………………………………………………………………………………… Topical Analgesic
Pain Relief
FDA Label NDC 70355-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Dongyang Yinda Biology Co., Ltd for the product Pain Relief (NDC 70355-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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. |
Otc - 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)
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Label (Label)
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