Active Ingredients
Allantoin 0.75%
Aluroderm Scar Patch
FDA Label NDC 76420-955
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Asclemed Usa, Inc. for the product Aluroderm Scar (NDC 76420-955). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor if, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
-Scar Management
-Temporarily protects and helps relieve chapped or cracked skin
Warnings
FOR EXTERNAL USE ONLY
Do Not Use
-On deep punctures, serious burns, or infected skin
When Using This Product
Avoid contact with the eyes
Stop Use And Ask Doctor If
-Condition worsens
-Excessive skin irritation develops
-Condition persists for more than 7 days, or condition clears up and occurs again within 3 days
If Pregnant Or Breastfeeding
Consult a physician before use
Keep Out Of Reach Of Children
If ingested, seek medical help or contact Poison Control immediately
Directions
Adults and Children 12 Years of Age and Older
-Clean and dry the affected area
-Apply as needed
Other Information
-Store at room temperature
Inactive Ingredients
Hyaluronic Acid, Taxifolin, Polyurethane, Sodium Carboxymethyl Cellulose
Questions Or Comments
Package Label.Principal Display Panel
Relabeled by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501
Label (Label)
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