Active Ingredient
Silicone gel 1%
Dermfree Scar Sheets Patch
FDA Label NDC 85248-110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Dermfree Scar Sheets (NDC 85248-110). 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, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Scar Reduction Sheets
Use
1.Clean and dry scar area.
2.Cut sheet according to the size and shape of the scar.
3. Peel off the liner from adhesive side of sheet.
4. Apply adhesive side of sheet directly on scar.Apply 4 hours a day for the first two days, 8 hours a day for the next two days, and then increase by 2 hours aday until you can wear it for 24 hours a day. each scar sheet can be used repeatedly and when another new scar patch becomes difficult to clean or paste replace another new scar sheet.
Warnings
Use this product once scar or wound has healed for at least 7 days, You may start using immediately on older scars, For old scars, the product can be used immediately.
Do not use on unhealed wounds.infected areas. or acne-prone skin.
If applied to unclean skin or worn too tightly, it may cause skin irritation or rashes. If this occurs, reduce wear time and ensure proper application.
it should be reduced to stick and stick for less time. Dosage and administration For external use only.
Do Not Use
Do not use on unhealed wounds, infected areas, or acne-prone skin.
If you have an open wound. It may disrupt healing and increase the risk of infection.
When Using
Use this product once scar or wound has healed for at least 7 days. You may start using immediately on older scars.
Stop Use
stop use on skin becomes broken, irritated, or inflamed
Ask Doctor
Stop use and ask a doctor if skin irritation, redness, or other adverse skin reactions occur.
Keep Oot Of Reach Of Children
Keep out of reach of children and pets.Store in a cool, dry place, away from direct sunlight.
Directions
Use this product once scar or wound has healed for at least 7 days, You may start using immediately on older scars, For old scars, the product can be used immediately.
Do not use on unhealed wounds.infected areas. or acne-prone skin.
If applied to unclean skin or worn too tightly, it may cause skin irritation or rashes. If this occurs, reduce wear time and ensure proper application.
it should be reduced to stick and stick for less time. Dosage and administration For external use only.
Inactive Ingredients
polydimethylsiloxane, polyurethane film, PET.
* Please review the disclaimer below.
