SPL v1
SPL
SPL Set ID 352699fa-f746-c931-e063-6394a90a6391
Route
EXTRACORPOREAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Kojic Acid (0.5 mL) Ascorbic Acid (0.1 mL)
Inactive Ingredients
Sodium Hyaluronate Propylene Glycol 2-hexanoate Biosaccharide Gum-2 Water Bisabolol 4-butylresorcinol Cetearyl Glucoside 1,2-hexanediol Camellia Japonica Seed Oil Niacinamide Butylene Glycol Cetearyl Alcohol Betaine Xanthan Gum Simmondsia Chinensis (jojoba) Seed Oil Glutathione Glyceryl Caprylate Methylparaben Panthenol

Identifiers & Packaging

Pill Appearance
Shape: semi-circle
Marketing Status
ANDA Active Since 2025-01-01

Description

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.


Medication Information

Warnings and Precautions

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.

Indications and Usage

Used to remove dark spots

Reduce pigmentation

For skin moisturizing

Dosage and Administration

For best results, use daily for 2-4 weeks

Description

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.

Section 50566-9

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.

Section 50567-7

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.

Section 50570-1

Do Not Apply on Broken or Irritated Skin.

Section 51727-6

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

Section 51945-4

Section 55105-1

Used to remove dark spots

Section 55106-9

ASCORBIC ACID, KOJIC ACID

Section 69761-5

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.


Structured Label Content

Indications and Usage (34067-9)

Used to remove dark spots

Reduce pigmentation

For skin moisturizing

Dosage and Administration (34068-7)

For best results, use daily for 2-4 weeks

Warnings and Precautions (34071-1)

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.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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.

Section 50570-1 (50570-1)

Do Not Apply on Broken or Irritated Skin.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Used to remove dark spots

Section 55106-9 (55106-9)

ASCORBIC ACID, KOJIC ACID

Section 69761-5 (69761-5)

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.


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