Dermovix
FDA Label NDC 69440-009
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 Dermovix (NDC 69440-009). 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
Allantoin 2.00%
Petrolatum 30.00%
Purpose
Skin Protectant
Skin Protectant
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If pregnant or breast feeding, contact physician prior to use.
Uses
• Scar Management • Temporarily protects minor cuts, scrapes and burns
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
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
• 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 lidocaine, vitamin E, onion extract
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
* Please review the disclaimer below.
