The following Structured Product Label (SPL) was submitted to the FDA by Alivio Medical Products, Llc for the product Premium Scar Patch (NDC 69512-020). 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 description, indications & usage, warnings, dosage & administration, storage and handling, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient
Allantoin 2.00 %
Lidocaine 4.00 %
Pterolatum 30.00 %
Purpose
Allantoin 2.00 % ........ Skin Protectant
Lidocaine 4.00 % ........ Topical Anesthetic
Petrolatum 30.00 %..... Skin Protectant
Keep out of reach of children. If pregnant or breastfeeding, contact physician prior to use
Questions or comments? call weekdays from 9 AM to 5 PM CST 800-914-7435
Uses
- Scar Management - Temporarily protects minor cuts, scrapes and burns
-Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations
Warnings
For external use only
Do not use
-on deep or puncture wounds, animal bites, serious burns
-in large quantities, particularly over raw surfaces or blistered areas
When using this product
-avoid contact with eyes
Stop use and ask a doctor if
-condition worsens symptoms last more than 7 days or clear up and occur again within a few days
Directions:
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 -do not use mesh for longer than 5 consecutive days -children under 12 should consult
physician prior to use
Other Information: store below 25C (77F), avoid direct sunlight
Copy Of Label (Scar Patch)
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