Otc - Active Ingredient
DL-Camphor 17.05 mg
L-Menthol 45.45 mg
Methyl Salicylate 45.45 mg
Sinsinpas Arex Pain Relieving Patch, Medium Patch
FDA Label NDC 55264-022
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 Pain Relieving Patch, Medium (NDC 55264-022). 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, otc - do not use, otc - pregnancy or breast feeding, otc - stop use, otc - when using, 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
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant and/or breast feeding, ask a health professional before use
Otc - Stop Use
Stop use and ask a doctor if
Rash, itching, or excessive skin irritation develops
Condition worsens
Symptoms persist for longer than 7 days
Symptoms clear up and reoccur within a few days
Otc - When Using
When using this product
Do not use other than directed
Avoid contact with eyes, mucous membranes, and rashes
Warnings And Precautions
This product contains natural rubber which may cause allergic reactions.
Dosage & Administration
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.
Children under 12 years of age:
Consult a doctor.
Storage And Handling
- avoid storing product in direct sunlight
- protect from excessive moisture
Inactive Ingredient
Mentha Oil, Zinc Oxide, Benzyl Nicothinamide, Butylated Hydroxytoluene, Calcium Carbonate, Glyceryl Rosinate, Natural Rubber, Polyisobutylene, Polybutene, Quintone, Vanillyl Nonylamide, YSResin.
Manufactured By:
SINSIN PHARM. CO., LTD.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
* Please review the disclaimer below.
