Active Ingredients
L-Menthol 76.8mg
Methyl Salicylate 57.6mg
DL-Camphor 96.0mg
Sinsinpas Arex Flex Gel Pain Relieving Patch
FDA Label NDC 55264-116
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 Flex Gel Pain Relieving Patch (NDC 55264-116). 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, indications & usage, warnings, keep out or reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with:
- Arthritis
- Simple backache
- Strains
- Bruises
- Sprains
Warnings
For external use only
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Do not use
- on wounds or damaged skin
- if you are allergic to any ingredients of this product
- with a heating pad
- use only as directed
- avoid contact with eyes, mucous membranes, and rashes
- skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
- condition worsens
- symptoms persist for longer than 7 days
- symptoms clear up and reoccur within a few days
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Or Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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 times daily
■ remove patch from skin after at most 8 hours of application
children under 12 years of age: Consult a doctor
Other Information
■ avoid storing product in direct sunlight
■ protect product from excessive moisture
Inactive Ingredients
Butylated hydroxytoluene, Methylparaben, Polysorbate 80, Castor Oil, D-Sorbitol Solution,
Concentrated Glycerin, Dihydroxyaluminum, Aminoacetate, Disodium Edetate Hydrate, Carboxymethylcellulose sodium, Kaolin, Titanium Dioxide, Sodium Polyacrylate, Aloe Vera Gel, Gelatin, Nikasol TS-620, Tartaric Acid, Nonylic acid vanillyamide, Purified Water
Package Label.Principal Display Panel
* Please review the disclaimer below.
