Active Ingredients
Chitosan
Vial Kit3.98
FDA Label NDC 80851-302
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oxytical for the product Vial Kit3.98 (NDC 80851-302). 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, use, directions, when using, ingredient, warnings, stop using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin regeneration and Wrinkle relief
Use
The skin's surface appears firmer and smoother with a more youthful look. Remodels the facial contours and reduces the thickness of subcutaneous fatty tissue helping to reduce the "double chin effect" providing you with a youthful complexion. Reinforces skin elasticity to provide plump and radiant complexion.
Directions
[Preparation stage]
After cleansing, use toner to clean up the skin.
It must be used only after cleansing is complete, and especially pay attention to the cleanliness of your hands.
If you use it after exfoliation, you can get more satisfactory results, and it is more effective if you give a simple massage before use.
[Application stage]
1. Prepare Core peptide(1st), Stable Chitin(2nd) and a syringe.
2. Core Peptide(1st) only opens the plastic cap.
3. A syringe inlet is injected into the center of the hole at the top of the Core Peptide(1st) to suction. (Total 3ml based on syringe).
After the syringe is removed, the inlet is automatically sealed to prevent outside air from entering.
4. Open the Stable Chitin(2nd) after referring to the precautions and inject the Core Peptide(1st).
Due to the nature of the Stable Chitin component, it is not soluble in ampoule other than Core Peptide. (Not compatible)
5. Close the vial opening of the Stable Chitin(2nd) with an elastomer tube and shake to dissolve the Stable Chitin.
Check with eyes and if the Stable Chitin component does not appear in the form of a thread (slightly thick), apply it to the skin.
When Using
Although it can be used immediately after melting, it is recommended to use after 12 hours after mixing the product and closing it with an elastomer tube after mixing the product to increase the activity and maximize the efficacy due to the nature of the formulation.
After blending, only the elastomer tube is closed and stored at room temperature fresh out of direct sunlight.
(Up to 21 days)
Ingredient
Chitosan
Warnings
For external use only.
Keep away from heat.
Stop Using
Stop use and ask a physician if skin irritation and redness occurs more that 72 hours.
Keep Out Of Reach Of Children
Keep out of reach of children, if swallowed, get medical help right away.
Package Label
0.02ml Ndc:80851-302-01 Label (Oxytical)
* Please review the disclaimer below.
