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FDA Approval

YVTYVT DARK SPOT

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
May 15, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Kojic acid(1 g in 100 mL)
Vitamin C(2 g in 100 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Zhejiang Ayan Biotech Co., Ltd.

Beijing JUNGE Technology Co., Ltd.

Beijing JUNGE Technology Co., Ltd.

544377996

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

YVTYVT DARK SPOT

Product Details

NDC Product Code
85212-0040
Application Number
ANDA075357
Marketing Category
ANDA (C73584)
Route of Administration
EXTRACORPOREAL
Effective Date
May 15, 2025
CETEARYL GLUCOSIDEInactive
Code: 09FUA47KNAClass: IACTQuantity: 1 mL in 100 mL
GLYCERYL CAPRYLATEInactive
Code: TM2TZD4G4AClass: IACTQuantity: 0.1 mL in 100 mL
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 0.1 mL in 100 mL
PANTHENOLInactive
Code: WV9CM0O67ZClass: IACTQuantity: 0.5 mL in 100 mL
SODIUM HYALURONATEInactive
Code: YSE9PPT4THClass: IACTQuantity: 0.5 mL in 100 mL
PROPYLENE GLYCOL 2-HEXANOATEInactive
Code: 39RQR15921Class: IACTQuantity: 0.1 mL in 100 mL
BIOSACCHARIDE GUM-2Inactive
Code: UVQ34I5XKQClass: IACTQuantity: 1 mL in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACTQuantity: 78.6 mL in 100 mL
BISABOLOLInactive
Code: 24WE03BX2TClass: IACTQuantity: 0.5 mL in 100 mL
Code: 6K23F1TT52Class: ACTIBQuantity: 1 g in 100 mL
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 2 g in 100 mL
4-BUTYLRESORCINOLInactive
Code: 2IK4UQ3ZGAClass: IACTQuantity: 2 mL in 100 mL
1,2-HEXANEDIOLInactive
Code: TR046Y3K1GClass: IACTQuantity: 0.5 mL in 100 mL
CAMELLIA JAPONICA SEED OILInactive
Code: U37N0S910TClass: IACTQuantity: 1 mL in 100 mL
NIACINAMIDEInactive
Code: 25X51I8RD4Class: IACTQuantity: 1 mL in 100 mL
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RAClass: IACTQuantity: 5 mL in 100 mL
CETEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACTQuantity: 1 mL in 100 mL
BETAINEInactive
Code: 3SCV180C9WClass: IACTQuantity: 2 mL in 100 mL
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACTQuantity: 0.1 mL in 100 mL
SIMMONDSIA CHINENSIS (JOJOBA) SEED OILInactive
Code: 724GKU717MClass: IACTQuantity: 1 mL in 100 mL
GLUTATHIONEInactive
Code: GAN16C9B8OClass: IACTQuantity: 1 mL in 100 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YVTYVT Dark Spot REMOVER


INDICATIONS & USAGE SECTION

Used to remove dark spots
Reduce pigmentation
For skin moisturizing

DOSAGE & ADMINISTRATION SECTION

For best results, use daily for 2-4 weeks


WARNINGS SECTION

For External Use Only.
Avoid Direct Contact with Eyes.
If the product gets into your eyes, rinse immediately with plenty of water.
Discontinue Use if Irritation Occurs: If redness, itching, or irritation develops, stop use and consult a dermatologist.
Do Not Apply on Broken or Irritated Skin. Keep Out of Reach of Children.


STORAGE AND HANDLING SECTION


OTC - ACTIVE INGREDIENT SECTION

ASCORBIC ACID, KOJIC ACID

OTC - PURPOSE SECTION

Used to remove dark spots

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - DO NOT USE SECTION

Do Not Apply on Broken or Irritated Skin.

OTC - STOP USE SECTION

If the product gets into your eyes, rinse immediately with plenty of water.
Discontinue Use if Irritation Occurs: If redness, itching, or irritation develops, stop use and consult a dermatologist.

OTC - WHEN USING SECTION

Step 1: Cleanse skin to remove impurities.
Step 2: Apply appropriate amount post - cleansing.
Step 3: Use before heavy moisturizers or oils for better absorption.


ALARMS

For External Use Only.
Avoid Direct Contact with Eyes. If the product gets into your eyes, rinse immediately with plenty of water.
Discontinue Use if Irritation Occurs: If redness, itching, or irritation develops, stop use and consult a dermatologist.
Use Sunscreen: Always use sunscreen during the day while using this product, as some ingredients may increase sensitivity to sunlight.
Do Not Apply on Broken or Irritated Skin.
Keep Out of Reach of Children.


INACTIVE INGREDIENT SECTION

WATER
BUTYLENE GLYCOL
BETAINE
4-BUTYLRESORCINOL
GLUTATHIONE
NIACINAMIDE
CAMELLIA JAPONICA SEED OIL
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
CETEARYL ALCOHOL
CETEARYL GLUCOSIDE
BIOSACCHARIDE GUM-2
PANTHENOL
BISABOLOL
1,2-HEXANEDIOL
SODIUM HYALURONATE
XANTHAN GUM
PROPYLENE GLYCOL
METHYLPARABEN
GLYCERYL CAPRYLATE


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