Otc - Active Ingredient
Dimethicone 3%
Ascorbic Acid 1%
Tocopherol 0.2%
Panthenol 0.2%
Allantoin 0.2%
Silicone Scar Cream
FDA Label NDC 84763-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd for the product Silicone Scar Cream (NDC 84763-007). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Advanced Scar Gel Reduce theAppearance of NEW & OLD Scars
Indications & Usage
It is primarily used to reduce and improve the appearance ofscars, lighten the color and thickness of scars, improve skinelasticity, and help restore smoother skin texture. Theingredients are mild and non-irritating, suitable for all kindsof scars.
Warnings
For external use only
Otc - Do Not Use
1. Do not use on open wounds, unhealed skin, or mucousmembranes.
Otc - When Using
3. lf pregnant or breast-feeding, ask a health professionalbefore use.
4. Keep out of reach of children. if product is swallowed, getmedical help or contact a Poison control Center immediately.
Otc - Stop Use
2. Stop use and ask a doctor if the scarred area becomesred, swollen, infected, or exhibits other abnormal conditions.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. if product is swallowed, getmedical help or contact a Poison control Center immediately.
Dosage & Administration
1. Before use, clean and dry the area where the scar creamwill be applied.
2. Take an appropriate amount of scar cream and apply itevenly on the scar area.
3. Gently massage the area to help absorption.
4. lt is recommended to use it 2-3 times a day, depending onthe recovery of the scar.
Inactive Ingredient
Water
Glycerin
Mineral Oil
Squalane
Caprylic/Capric Triglyceride
Centella Asiatica Extract
Cetearyl Glucoside
Cetearyl Alcohol
PEG-100 Stearate
Fish Liver Oil
Glyceryl Stearate
Phenoxyethanol
Hydrolyzed Collagen
Carbomer
Arginine
Methylparaben
Hyaluronic Acid
Rosa Rugosa Flower Oil
Retinol
Package Label.Principal Display Panel
Label (Label)
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