Active Ingredient
Capsaicin 0.025%
Walgreens Capsaicin Hot Patch
FDA Label NDC 0363-6691
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Walgreens Capsaicin Hot Patch (NDC 0363-6691). 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, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, and sprains
Warnings
For external use only
Allergy alert: If you are allergic or suspect you are allergic to the ingredients of this product, including chili peppers, consults with your physician before use.
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 stillc otnain the drug product that can produce serious adverse effects if a child or pets 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.
If Pregnant Or Breast-Feeding,
ask a physician before use.
Keep Out Of Reach Of Children.
If swallowed, contact a Poison Control Center (1-800-222-1222)
Directions
- Adults and children 12 years and older: clean and dry affected area
- remove patch from film
- apply to affected area not more than 3 to4 times daily
- use one patch for up to 8 hours
- discard patch after single use
- reseal pouch after opening
- Children under 12 years of age: ask a doctor.
Other Information
Store at room tempeature - do not exceed 86° Fahrenheit, 30 °Celsius
Inactive Ingredients
hydrogentated C6-20 polyolefin, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer
Principal Display Panel - 5.12 In X 7.09 In Carton Label
Walgreens
Compare to the active ingredient
in Salonpas ® Hot Capsicum Patch ††
Capsaicin
Hot Patch
Capsaicin 0.025% / Topical Analgesic
Medicated
- For the temporary relief of minor aches & pains of muscles & joints associated with simple backaches, arthritis, strains, bruises & sprains
3 PATCHES
5.12 IN x 7.09 IN
(13 cm X 18 cm) EACH
Caution: This product contains natural rubber latex which may cause allergic reactions
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Pouch (Wag P 766691 Capsaicinhotpatch Pouch 260328(1)ok 1)
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