FDA Label for Sinsinpas Arex Flex Gel Pain Relieving Patch
View Indications, Usage & Precautions
Sinsinpas Arex Flex Gel Pain Relieving Patch Product Label
The following document was submitted to the FDA by the labeler of this product Sinsin Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
L-Menthol 76.8mg
Methyl Salicylate 57.6mg
DL-Camphor 96.0mg
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
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