Vial Kit3.98

Manufacturer
Oxytical
Effective date
2022-11-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:51:30

Label at a glance#

ProductVial Kit3.98
Active ingredientCHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S)
Label structure10 sections

Dosage and administration

[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 Pepti...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Chitosan

Purpose

OTC - PURPOSE SECTION

Skin regeneration and Wrinkle relief

Use

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

[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

OTC - WHEN USING SECTION

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

INACTIVE INGREDIENT SECTION

Chitosan

Warnings

WARNINGS SECTION

For external use only.

Keep away from heat.

Stop Using

OTC - STOP USE SECTION

Stop use and ask a physician if skin irritation and redness occurs more that 72 hours.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, if swallowed, get medical help right away.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.02mL NDC:80851-302-01 Label0.02mL NDC:80851-302-01 Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80851-302-012024-01-30C16284748780-11030e365-51d1-111a-e063-dadaa90a10e2b3f6af61-2053-d091-e053-2a95a90a72f9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80851-302-01Vial Kit3.980.02 mL in 1 BOTTLE, GLASSLIQUID0.023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80851-302VIAL KIT3.98 (CHITOSAN) LIQUID [OXYTICAL]3Legacy NDC, 1 package rows20221114_b3f6af61-2053-d091-e053-2a95a90a72f9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80851-30280851-302-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ed68ab58-63b0-e7bc-e053-2a95a90af784b3f6af61-2053-d091-e053-2a95a90a72f92022-11-14WarningsExact identifier
spl id: ed68ab58-63b0-e7bc-e053-2a95a90af784
spl set id: b3f6af61-2053-d091-e053-2a95a90a72f9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.