Otc - Active Ingredient
- DL-Camphor
- L-Menthol
- Methyl Salicylate
Sinsinpas Arex Patch Large Patch
FDA Label NDC 55264-024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sinsin Pharmaceutical Co., Ltd. for the product Sinsinpas Arex Patch Large (NDC 55264-024). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, do not use, warnings and precautions, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Indications & Usage
For temporary relief of minor aches and pains of muscles and joints associated with:
- arthritis
- simple backache
- strains
- bruises
- sprains
Warnings
For external use only
Do Not Use
- on wounds or damaged skin
- if you are allergic to aspirin or salicylates
- with a heating pad
- with, or at the same time as, other external analgesic products
Warnings And Precautions
This product contains natural rubber latex which may cause allergic reactions.
Directions
Adults and children 12 years of age and over:
- Clean and dry affected area
- Remove patch from film
- Apply to affected area not more than 3 to 4 times daily for 7 days.
- Remove patch from skin after at most 8 hours application
- Consult a doctor
Children under 12 years of age:
Other Information
- avoid storing product in direct sunlight
- protect from excessive moisture
Inactive Ingredient
Benzyl Nicothinamide, Butylated Hydroxytoluene, Calcium Carbonate, Glyceryl Rosinate, Natural Rubber, Polyisobutylene, Polybutene, Quintone, Vanillyl Nonylamide, YSResin, Mentha oil, Zinc oxide
Other
SINSIN PHARM. CO., LTD.
Gyeonggi-do, Korea
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
* Please review the disclaimer below.
