Active Ingredients
Drug Facts (Drug Facts 16cm Box)
Methyl Salicylate 1%
Pro-sero Pain Relief
FDA Label NDC 80846-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tieh Leh Biotech Co., Ltd. for the product Pro-sero Pain Relief (NDC 80846-100). 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 ingredients, purpose, uses, warnings, alergy alert:, do not use, ask a doctor before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:
- arthritis
- simple backache
- sprains
- strains
- bruises
Warnings
For external use only
Alergy Alert:
If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Do Not Use
- on the face or rashes
- on wounds or damaged skin
- if allergic to any ingredient of this product
- on a child under 12 years of age with arthritis-like conditions
Ask A Doctor Before Use If
- you are allergic to topical products
When Using This Product
- wash hands after applying or removing patch
- avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
Stop Use And Ask A Doctor If
- rash, itching or skin irritaion develops
- condition worsens
- symptoms last for more than 7 days
- symptoms clear up and occur again within a few days
If Pregnant Or Breast-Feeding
- ask a health professional before use
Keep Our Of Reach Of Children. Package Not Child Resistant.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions
Adults and children 12 years of age and over:
- clean and dry affected area
- remove patch from film and apply to affected area
- leave in place for up to 8 to 12 hours
- apply a new patch up to 3 times daily
- Children under 12 years of age: Consult a doctor
Other Information
- store at 20 - 25 degrees Celsius (68-77 degrees Fahrenheit)
- avoid storing product in direct sunlight
- protect product from excessive moisture
- reseal unused patches in their pouch
- for some individuals, pain relief begins several hours after applying the patch
Inactive Ingredients
Clematis Chinensis Root, FD&C Yellow No. 5, Frankincense, Indigotindisulfonate Sodium, Momordica Cochinchinensis Seed, Myrrh, Ricinus Communis Seed, Rosin, Sesame Oil, Yellow Wax, Zinc Oxide
Questions Or Comments?
Visit www.pro-sero.com
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