Active Ingredient(S)
ALLANTOIN 10%
Scar Removal Cream
FDA Label NDC 84322-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Gaoye E-commerce Co., Ltd for the product Scar Removal Cream (NDC 84322-003). 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(s), purpose, use, warnings, 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
Purpose
Remove Scars
Use
Skin repair, burns, acene, keloids, c-section, stretch marks etc scar treatments
Warnings
* For external use only.
* Do not useon damaged or broken skin.
* If you feel uncomfortable, please stop using.
* Please test this creamon a small patch of your the inside of the arm if it is your first time using this cream.
* Stop and ask a doctor ifirritation or allergic reactions develop.
Do Not Use
Do not using children less than 2 months of age on open skin wounds.
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
• Stop use and ask a doctor if irritation or rash occurs .
• Keep out of reach of children.
• If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
• When using this product keep out of eyes, ears, and mouth. In case of contact with eyes ,rinse eyes thoroughly with water .
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
1. Clean and dry the scarred area.
2. Gently massage a small amount of Scar Gel onto the skin for 3-5 minutes for good absorption. Repeat 2-3 times a day.
3. Start using the scar gel only when new skin forms, which is usually 2-4 weeks after an injury or surgery. Ensure that any scabs have fallen off naturally and stitches have been removed before applying. Not for use on broken skin.
Other Information
•Please keep in a cool place
•And avoid high temperature and direct sunlight,
•Keep out of reach of children
Inactive Ingredients
Water, DIMETHICONE, Glycerin, Retinol, Propanol, Trehalose, Panthenol, Vitamin E (Tocophero),
Carbomer, Triethanolamine, Nitrosin, Phenoxy Ethanol, Ethylglycerol
Package Label - Principal Display Panel
Label (Label)
* Please review the disclaimer below.
