Drug Facts
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Plantar Patch
FDA Label NDC 71590-013
10 label sections · Submitted to the FDA by Active Intelligence, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Active Intelligence, Llc for the product Plantar Patch (NDC 71590-013). 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 ingredients, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Lidocaine 4%
Purpose
Topical analgesic
Use
for the temporary relief of pain
Warnings
for external use only
When using this product
use only as directed. Read and follow all directions and warnings on this carton
do not bandage tightly
avoid contact with eyes and mucous membranes
do not use at the same time as other topical analgesics
do not remove when wet or directly after shower, allow to dry and then slowly remove
Stop use and ask a doctor if
condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
you experience signs of skin injury, such as pain, swelling or blistering where the patch was applied
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
• If swallowed, get medical help or contact a Poison Control Center right away
Directions
adults and children over 12 years:
- apply patch for up to 12 hours of wear time
- apply 1 patch at a time to the affected area, not more than 2 to 3 times daily
- store in a cool dry place, in a resealable bag
children 12 years or younger: ask a doctor
Inactive Ingredients
Acrylic adhesive, Flaxseed oil, and Polysorbate 80
Other
Made in USA
For detailed usage instructions, scan the QR code or visit www.activeintell.com
Questions/Comments: (704) 769-0166
Manufactured and distributed by Active Intelligence, LLC -A Nutriband, Inc company: 100 Sweetree St
Cherryville, NC 28021
Package Label.Principal Display Panel
71590-013-10 (71590 013 10)
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