Bonicaeasex Hot Capsicum Pain Relieving Patch
FDA Label NDC 75568-042
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Planet (anhui) Pharmaceutical Co.,ltd for the product Bonicaeasex Hot Capsicum Pain Relieving (NDC 75568-042). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Capsicum extract 0.025% as Capsaicin
Purpose
Topical analgesic
Uses
For temporary relief of minor aches & pains of muscles & 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, 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
Stop Use And Ask A Doctor If
- skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
- conditions worsen- 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.
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 over:
• clean and dry affected area • remove patch from film • apply to affected area not more than 3 to 4 times daily • remove patch from the skin after at most 24 hours' application
Children under 12 years of age: consult a doctor
Other Information
• Avoid storing product in direct sunlight • Protect product from excessive moisture
Inactive Ingredients
• Propylene Glycol • Titanium Dioxide • Isopropyl Myristate
• Polyisobutylene • Vitamin E Acetate • Mineral Oil
• Dimethyl Isosorbide • Tri(2,4-Ditertrabutylphenyl)phosphiteester
• 3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid neopentanetetrayl ester
Questions Or Comments?
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