FDA Label for Meijer Capsaicin Heat Patch

View Indications, Usage & Precautions

Meijer Capsaicin Heat Patch Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution. 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 Ingredient



Capsaicin 0.025%


Purpose



Topical analgesic


Uses



Temporary relief of minor pain of muscles and joints associated with: arthritis, minor
backache, strains, sprains and bruises


Do Not Use



■ on wounds or damaged skin ■ with pain rubs, medicated lotions, creams or
ointments ■ with a heating pad.


When Using This Product



■ use only as directed ■ avoid contact with eyes, mucous membranes
or rashes ■ do not bandage tightly ■ discontinue use at least 1 hour before a bath or shower
■ do not use immediately after a bath or shower ■ do not microwave ■ dispose of used patch in
manner that always keeps product away from children and pets. Used patches still contain the
drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

■ use only as directed ■ avoid contact with eyes, mucous membranes
or rashes ■ do not bandage tightly ■ discontinue use at least 1 hour before a bath or shower
■ do not use immediately after a bath or shower ■ do not microwave ■ dispose of used patch in
manner that always keeps product away from children and pets. Used patches still contain the
drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.


Stop Use And Ask A Doctor If



■ skin reactions such as redness, itching, rash, excessive
irritation, burning sensation, swelling or blistering occur ■ condition worsens ■ symptoms persist
more than 7 days ■ symptoms clear and reoccur within a few days.


Keep Out Of Reach Of Children.



If swallowed, contact a poison control center (1-800-222-1222) right away

f swallowed, contact a poison control center (1-800-222-1222) right away.


Directions



Adults and children 12 years of age and over: Clean and dry affected area, free of lotions,
ointments and creams. Carefully remove backing starting at a corner. Apply sticky side of patch
to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary.
Maximum 3 patches per day. Discard patch after single use.
Children under 12 years of age: consult a physician.


Other Information



■ Avoid storage in direct sunlight ■ Protect patch from excessive moisture.


Inactive Ingredients



hydrogenated C6-20 polyolefin, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer


Questions Or Comments?



call 1-866-326-1313


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