Siterol
FDA Label NDC 69440-007
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 Siterol (NDC 69440-007). 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, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine HCL 3.99%
Menthol 1.00%
Purpose
Topical Analgesic
External Analgesic
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Consult physician for children under 12.
Uses
• temporary relief of pain associated with minor cuts, scrapes, and minor skin irritations
Warnings
For external use only
Do not use
• if pregnant or breastfeeding, consult physician prior to use
• in large quantities, particularly over raw surfaces or blistered areas
When using this product
• use only as directed • do not bandage tightly • avoid contact with eyes
• do not apply to open wounds or damaged skin
Stop use and ask a doctor if
• symptoms persist for more than seven days, discontinue use and consult physician
• swallowed, consult physician
Directions
How to apply • clean and dry affected area • remove patch from backing and apply to affected area • use only one patch at a time, and maximum of four patches/day • leave patch on affected area for upto 8-hours • do not use patches for longer than five consecutive days
Inactive Ingredient
Other ingredients aloe barbadensis leaf (aloe vera juice) gel, aqua (deionized water), arnica montana extract, boswellia serrata extract, camellia sinensis leaf (green tea) extract, carbomer, ethylhexylglycerin, glycerin, isopropyl myristate, PEG-8, phenoxyethanol, polysorbate-80, sodium lauryl sulfate, triethanolamine, FD C blue 1, FD C yellow 5
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
Siterol (Siterol)
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