Active Ingredient
Menthol 5%
Walgreens Cold Therapy Pain Relieving Patch
FDA Label NDC 0363-6669
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 Cold Therapy Pain Relieving Patch (NDC 0363-6669). 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 temporary relief of minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only
Do Not Use
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any ingredients of this product
When Using This Product
- use only as directed
- avoid contact with the eyes or mucous membranes
- do not apply to wounds or damaged skin
- do not apply to irritated skin or if excessive irritation develops
- do not bandage tightly or use with heating pad
- wash hands thoroughly after applying
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
- redness is present
- irritation develops
- symptoms persist for more than 10 days in the case of arthritis
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove the remianing film while pressing the patch to skin. Use on affected area not more than 3 to 4 times daily.
- discard patch after single use
- children under 12 years of age: consult a physician
- wash hands after use with cool water
Other Information
- store at 20-25°C (68-77°F)
- store in a cool dry place, away from direct sunlight
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Cellulose Gum, Diazolidinyl Urea, Dihydoxyaluminum Aminoacetate, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.
Principal Display Panel - 3.94 In X 5.51 In Carton Label
Walgreens
Compare to the active ingredient in
BIOFREEZE ® Large Patches ††
Cold Therapy
Pain Relieving
Patch
Menthol 5% / Topical Analgesic
Cooling Pain Relief
- Cold therapy formula for sore muscles, backaches & joint pain
- Targeted pain relief
- Single-use patch
- Apply up to 8 hours
5 Large patches
Menthol scent
3.94 IN x 5.51 IN
(10 cm x 14 cm) EACH
Carton (766669 Coldtherapypainrelievingpatch Box 1)
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