Active Ingredient Section
Active Ingredient
Allantoin 2.00 %
Lidocaine 4.00 %
Petrolatum 30.00 %
Scadexe
FDA Label NDC 69329-040
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Patchwerx Labs, Inc. for the product Scadexe (NDC 69329-040). 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 ingredient section, ask doctor section, do not use section, keep out of reach of children, pregnancy or breast feeding, purpose, questions, stop use section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ask Doctor Section
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
Do Not Use Section
- on deep or puncture wounds, animal bites, serious burns
- in large quantities, particularly over raw surfaces or blistered areas
Keep Out Of Reach Of Children
Keep out of reach of children. If pregnant or breastfeeding, contact physician prior to use
Pregnancy Or Breast Feeding
If pregnant or breastfeeding, contact physician prior to use
Purpose
- Temporarily protects minor cuts , scrapes and burns
- Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations
Questions
For questions or comments please call 800-317-2910
Stop Use Section
Stop use if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.
When Using Section
How to apply
- clean and dry affected area
- remove mesh from backing and apply to affected area
- use only one mesh at a time, and maximum of four mesh / day
- leave mesh on affected area for up to 8 hours
- children under 12 should consult
Package Label
Scadexe_large_low_res (Scadexe Large Low Res)
Warnings
Stop use if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.
Do not use if pregnant.
Keep away from Children
Inactive Ingredients These Highlights Do Not Include All The Information Needed To Use
ONION
ALPHA-TOCOPHEROL
* Please review the disclaimer below.
