84356-002

84356-002
SPL v1
SPL
SPL Set ID 37ad0c11-bb94-dd70-e063-6394a90a705d
Route
TOPICAL
Published
Effective Date 2025-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (3 g) Salicylic Acid (2 g) Azelaic Acid (10 g)
Inactive Ingredients
Glycerin Butyrospermum Parkii (shea) Butter Aqua Phenoxyethanol Melaleuca Alternifolia (tea Tree) Leaf Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-16

Description

Niacinamide 3% Azelaic Acid 10% Salicylic Acid 2%

Purpose

Acne treatment, exfoliation Fades dark spots, antibacterial Reduces oiliness, improves skin tone


Medication Information

Purpose

Acne treatment, exfoliation

Fades dark spots, antibacterial

Reduces oiliness, improves skin tone



Description

Niacinamide 3% Azelaic Acid 10% Salicylic Acid 2%

Use

-Treats acne and prevents breakouts

-Fades post-acne dark spots and hyperpigmentation

- Brightens skin tone and improves texture

-Reduces excess oil and unclogs pores



Section 50565-1

If swallowed, get medical help or contact Poison Control right away.



Section 50566-9

Skin becomes excessively red, swollen, or painful.

No improvement after 8 weeks of use.



Section 50567-7

May cause mild dryness or peeling (use moisturizer).

Avoid contact with eyes. If contact occurs, rinse immediately.

Sun sensitivity may increase—use sunscreen daily.

Discontinue use if severe irritation occurs.



Warnings

If severe irritation occurs, please stop using immediately

Directions

-Wet face with water.

-Gently lather the soap and apply to affected areas.

-Rinse thoroughly and pat dry.

-Use up to twice daily, morning and night.

-For best results: Follow with a moisturizer.



Do Not Use

If allergic to any ingredient (especially tea tree oil).

On broken or severely irritated skin.

With other acne medications unless directed by a doctor



Other Information

Store in a cool, dry place (20-25°C / 68-77°F).

Avoid excessive moisture to preserve soap quality.

For external use only.



Active Ingredient(s)

Niacinamide 3%

Azelaic Acid 10%

Salicylic Acid 2%

Inactive Ingredients

Aqua, Butyrospermum Parkii (Shea) Butter, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol

Package Label Principal Display Panel


Structured Label Content

Use

-Treats acne and prevents breakouts

-Fades post-acne dark spots and hyperpigmentation

- Brightens skin tone and improves texture

-Reduces excess oil and unclogs pores



Section 50565-1 (50565-1)

If swallowed, get medical help or contact Poison Control right away.



Section 50566-9 (50566-9)

Skin becomes excessively red, swollen, or painful.

No improvement after 8 weeks of use.



Section 50567-7 (50567-7)

May cause mild dryness or peeling (use moisturizer).

Avoid contact with eyes. If contact occurs, rinse immediately.

Sun sensitivity may increase—use sunscreen daily.

Discontinue use if severe irritation occurs.



Purpose

Acne treatment, exfoliation

Fades dark spots, antibacterial

Reduces oiliness, improves skin tone



Warnings

If severe irritation occurs, please stop using immediately

Directions

-Wet face with water.

-Gently lather the soap and apply to affected areas.

-Rinse thoroughly and pat dry.

-Use up to twice daily, morning and night.

-For best results: Follow with a moisturizer.



Do Not Use (Do not use)

If allergic to any ingredient (especially tea tree oil).

On broken or severely irritated skin.

With other acne medications unless directed by a doctor



Other Information (Other information)

Store in a cool, dry place (20-25°C / 68-77°F).

Avoid excessive moisture to preserve soap quality.

For external use only.



Active Ingredient(s)

Niacinamide 3%

Azelaic Acid 10%

Salicylic Acid 2%

Inactive Ingredients (Inactive ingredients)

Aqua, Butyrospermum Parkii (Shea) Butter, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol

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


Advanced Ingredient Data


Raw Label Data

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