The following Structured Product Label (SPL) was submitted to the FDA by Dw Support Llc for the product Parche Frio (NDC 87943-012). 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 dosage & administration, warnings, inactive ingredients, indications & usage, otc – keep out of reach of children, otc – purpose, parche frio principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Adults and children 12 years of age and older: Clean and dry affected area. Remove patch from film and apply to skin. Apply to affected area not more than 3 to 4 times daily. Remove patch from skin after at most 8 hours.
Children under 12 years of age: Consult a doctor.
For external use only
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
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 eyes or mucous membranes
• do not bandage tightly
• discontinue use at least 1 hour before bathing or showering
• do not use immediately after bathing or showering
Stop use and ask a doctor if:
• skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
• conditions worsen or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use.
Sunflower Extract, Rhubarb Extract, Myrrh Gum, Natural Rubber, Zinc Oxide, Adhesive
For the temporary relief of minor aches and pains of muscles and joints associated with:
• simple backache • arthritis • strains • bruises • sprains
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Topical Analgesic
* Please review the disclaimer below.
