Thritex
FDA Label NDC 69440-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Binger Consulting Corporation for the product Thritex (NDC 69440-008). 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, otc - keep out of reach of children, uses, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 5.00%
Purpose
Analgesic/Counterirritant
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Consult physician for children under 12.
Uses
• temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness
Warnings
For external use only
Do not use
• on wounds or damaged skin
• if you are allergic to Menthol
When using this product
• do not cover with bandage
• use only as directed
• avoid contact with eyes and mucous membranes
Stop use and ask a doctor if
• conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days
• rash, itching or excessive skin irritation occurs
Dosage & Administration
Directions adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
How to apply
• clean and dry affected area
• cut open pouch and remove patch
• remove protective film and apply directly to area of pain
• apply to affected area not more than 3 times daily
• wash hands with soap after applying patch
• reseal pouch containing unused patches.
Inactive Ingredient
Other ingredients water, capsaicin, glycerin, sodium polyacrylate, polysorbate 80, aloe barbadensis leaf (aloe vera leaf) juice, EDTA disodium salt, diazolidinyl urea, methylparaben, iodopropynyl butylcarbamate, propylparaben
Otc - Questions
Questions or comments? call weekdays from 9 AM to 5 PM PST 888-501-5651
Storage And Handling
Other information store below 25°C (77°F), avoid direct sunlight
Packaging
Label2 (Thritex)
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