Active Ingredient
Capsaicin 0.025%
Meijer Capsaicin Heat Patch
FDA Label NDC 79481-0064
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution for the product Meijer Capsaicin Heat Patch (NDC 79481-0064). 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 ingredient, purpose, uses, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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