FDA Label for Bt Pain Relief

View Indications, Usage & Precautions

Bt Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Big 5 Nutrition Llc. 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.

Drug Facts




Active Ingredients



Menthol 5%
Methyl Salicylate 1%


Purpose



External analgesic


Uses



For the temporary relief of minor aches and pains of muscles associated with

•strains •bruises •sprains •simple backache •cold and dampness


Warnings



For external use only

Do not use

•on wounds •irritated or damaged skin •sensitive skin

•with a heating pad •if pregnant

•with, or as the same time as, other external analgesic products

•if allergic to aspirin or salicylates

•if allergic to any ingredients of this product

When using this product

•avoid contact with the eyes

•do not bandage tightly

•do not apply to wounds or damaged skin

•do not use more than 2 plasters a day

•do not use 1 hour before or after bathing

Stop use and ask a doctor if

•condition worsens

•symptoms persist for more than 7 days

•symptoms clear up and occur again within a few days

•excessive irritation of the skin develops

•rashes, itching or redness are present

•side effects occur

If pregnant, ask a health professional before use.


Directions



• Clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch.
•Patch will remain effective for 6 hours.
•Avoid using the same patch on the same area for more than 6 hours.
•Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.
•Wet patch with warm water before removing from skin
•Children under 2 years of age: Do not use or consult a doctor.


Other Information



•Store unused patch in the pouch
•Store at room temperature, 20° to 25° C (68°  to 77° F)


Inactive Ingredients



Cinnamomum kanehirae Hayata Essential Oil, Chinese Clematidis Root & Rhizome, Yellow wax, Momordica cochinchinensis seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD&C Blue No. 2, FD&C Yellow No. 4, Zinc Oxide


Packaging




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