84356-004

84356-004
SPL v1
SPL
SPL Set ID 37d02e3b-383f-0628-e063-6394a90a7aa2
Route
TOPICAL
Published
Effective Date 2025-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Retinol (0.1 g) Hyaluronic Acid (1.5 g) Caffeine (3 g) Niacinamide (5 g)
Inactive Ingredients
Aqua Glycerin Centella Asiatica Triterpenoids Ethylhexylglycerin Peg-40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-18

Description

Retinol 0.1% Niacinamide 5% Caffeine 3% Hyaluronic Acid 1.5%

Purpose

Anti-wrinkle Dark circle reducer Puffiness reducer Fine line smoothe


Medication Information

Purpose

Anti-wrinkle

Dark circle reducer

Puffiness reducer

Fine line smoothe



Description

Retinol 0.1% Niacinamide 5% Caffeine 3% Hyaluronic Acid 1.5%

Use

Temporarily im proves the appearance of:

■Wrinkles ■Aging signs ■Dark circles under eyes ■Puffiness



Section 50565-1

Store in locked cabinets≥1.5 meters above Aoor level Immediately call Poison Control Center if ingested



Section 50566-9

Pregnant, planning pregnancy, or breast-feedingM [ J sing prescription retinoids (e.g, tretinoin) or strong exfoliants



Section 50567-7

top use and ask a doctor if:

1. Rash, peeling, or severe irritation occurs

2. Signs of allergic reaction appear (swelling, itching, redness) When using this product:

① Avoid contact with eyes. If occurs, rinse thoroughly with water

② Do not use on broken skin

3. Increased sun sensitivity may occur. Use sunscreen (SPF 30+) daily Consult a doctor before use if:

① Pregnant, planning pregnancy, or breast-feeding ② Using prescription retinoids (e.g., tretinoin) or strong exfoliants



Warnings

Do not use on injured wounds

Directions

■ Apply l mask to clean skin around eyes. Leave for 15-20 minutes.

■ Avoid contact with eyes

■ Use up to 3 times weekly.

Do Not Use

Not for use on children under 12. Do not use on broken skin



Other Information

■Store at 15-25°C (59-77°F) in original packaging

■Avoid excessive heat and direct sunlight

Active Ingredient(s)

Retinol 0.1%

Niacinamide 5%

Caffeine 3%

Hyaluronic Acid 1.5%

Inactive Ingredients

Aqua, Glycerin, Centella Asiatica Extract, Ethylhexylglycerin, PEG-40 Hydrogenated Castor Oil

Package Label Principal Display Panel


Structured Label Content

Use

Temporarily im proves the appearance of:

■Wrinkles ■Aging signs ■Dark circles under eyes ■Puffiness



Section 50565-1 (50565-1)

Store in locked cabinets≥1.5 meters above Aoor level Immediately call Poison Control Center if ingested



Section 50566-9 (50566-9)

Pregnant, planning pregnancy, or breast-feedingM [ J sing prescription retinoids (e.g, tretinoin) or strong exfoliants



Section 50567-7 (50567-7)

top use and ask a doctor if:

1. Rash, peeling, or severe irritation occurs

2. Signs of allergic reaction appear (swelling, itching, redness) When using this product:

① Avoid contact with eyes. If occurs, rinse thoroughly with water

② Do not use on broken skin

3. Increased sun sensitivity may occur. Use sunscreen (SPF 30+) daily Consult a doctor before use if:

① Pregnant, planning pregnancy, or breast-feeding ② Using prescription retinoids (e.g., tretinoin) or strong exfoliants



Purpose

Anti-wrinkle

Dark circle reducer

Puffiness reducer

Fine line smoothe



Warnings

Do not use on injured wounds

Directions

■ Apply l mask to clean skin around eyes. Leave for 15-20 minutes.

■ Avoid contact with eyes

■ Use up to 3 times weekly.

Do Not Use (Do not use)

Not for use on children under 12. Do not use on broken skin



Other Information (Other information)

■Store at 15-25°C (59-77°F) in original packaging

■Avoid excessive heat and direct sunlight

Active Ingredient(s)

Retinol 0.1%

Niacinamide 5%

Caffeine 3%

Hyaluronic Acid 1.5%

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Centella Asiatica Extract, Ethylhexylglycerin, PEG-40 Hydrogenated Castor Oil

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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