FDA Label for Pain Reliefpatches Patches

View Indications, Usage & Precautions

Pain Reliefpatches Patches Product Label

The following document was submitted to the FDA by the labeler of this product Shanghai Aquagel Bio-plymer 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.

Otc - Active Ingredient



Active ingredients

For External Use Only

DL-Camphor 1.2%.......................................................................................................................................Topical analgesic

L-Menthol 4.0%..........................................................................................................................................Topical analgesic

Methyl Salicylate 6.3%................................................................................................................................Topical analgesic


Otc - Purpose



Uses

For temporary relief of minor aches and pains associated with:

Arthritis

Backaches

Sprains

Strains

Bruises


Warnings



Warnings

For External Use Only


Indications & Usage



Do not use

other than as directed on wounds, damaged or irritated skin in combination with other external analgesic

products, ointments, creams or with a heating pad. in contact with eyes or mucous membranes. if you are

allergic to any ingredient in this product. if you have a history of allergic reactions to this or similar products


Otc - Stop Use



Stop Use and ask a doctor if

rash, itching or excessive skin irritation develops

condition worsens

symptoms persist for more than 7 days

if symptoms subside and then reappear within a few days.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.


Dosage & Administration



Directions

Adults and children 12 years of age and over: Clean and dry the affected area. Remove patch from film backing. Adhere

to area for no more than 8 hours at a time, not more than 3 times per day, and for no more than 7 days continuously.

Children under 12 years of age: Consult a doctor before use.


Storage And Handling



Other information

Store in a cool dry place. Avoid direct sunlight.


Inactive Ingredient



Inactive ingredients Ammonium Stearate, Calcium Carbonate, Glyceryl Abietate, Isopropyl Myristate, Natural

Rubber, Polybutene, Polyisobutylene, Propylene Carbonate, Styrene Copolymer, YS Resin, Zinc Oxide


Package Label.Principal Display Panel




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