Active Ingredients
Menthol 5.00%
Capsaicin 0.0375%
Ultimate Topical Pain Relief Patch
FDA Label NDC 69159-910
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foshan Aqua Gel Biotech Co.,ltd. for the product Ultimate Topical Pain Relief Patch (NDC 69159-910). 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 ingredients, purpose:, uses:, warnings, stop use and ask a doctor if, if pregnant or breast feeding, 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:
External Analgesic/Counterirritant
External Analgesic/Counterirritant
Uses:
Temporarily relieves minor aches and muscle pain associated with simple back ache, arthritis, strains and sprains. Use only as directed.
Warnings
- For external useonly.
- Avoid contact with eyes and mucous membranes.
- Do not use on wounds or damaged skin.
- Do not cover with bandage.
- Do not use if you are allergic to Menthol.
- Consult physician for use on children under 12.
Stop Use And Ask A Doctor If
conditions worsen, if symptoms persist for more than 7 days or clear up and occur again with a few days, or if a rash,
itching or excessive skin irritation occurs.
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 and over apply to affected area; change patch 1 to 2 times daily
- Children under 12 years: Consult physician before use.
Other Information
Store below 25°C (77°F). Avoid direct sunilght.
Inactive Ingredients:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodium ,Glycerin, Iodopropynyl Butylcarbamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, and Water.
Questions Or Comments?
Please call 1-800-290-6816 (Mon-Fri 9AM-5PM CST)
Dosage And Administration
Ultimate Topical Pain Relief Patch contains 0.0375% capsaicin and 5.00% menthol
* Please review the disclaimer below.
