84356-003

84356-003
SPL v1
SPL
SPL Set ID 37ad7cd7-92df-82d9-e063-6294a90a0f04
Route
TOPICAL
Published
Effective Date 2025-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Panthenol Azelaic Acid Sodium Hyaluronate Phenoxyethanol Aqua Niacinamide Butylene Glycol Ethylhexylglycerin

Identifiers & Packaging

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

Description

Salicylic Acid 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment



Description

Salicylic Acid 2%

Use

■ Treats acne and prevents breakouts

■ Removes blackheads and minimizes pores

■ Gently exfoliates dead skin cells

■ Improves skin texture and tone

Section 50565-1

Contains salicylic acid; harmful if swallowed.

If ingested, contact Poison Control immediately (U.S.: 1-800-222-1222).



Section 50566-9

Severe irritation, rash, or peeling develops.

No improvement after 12 weeks of regular use.

Signs of allergic reaction (swelling, itching, dificulty breathing). .



Section 50567-7

■ Mild tingling or redness may occur initially (discontinue if severe).

■ Avoid sun exposure after use; apply sunscreen daily.

■ Do not combine with harsh scrubs or alcohol-based products.

■ Keep away from eyes and mucous membranes.

Warnings

Do not use on injured wounds

Directions

■ Cleanse and dry face thoroughly.

■ Gently wipe the pad over affected areas (avoid eye contour).

■ Use once daily (evening recommended) for normal skin, or every other day for sensitive skin.

■ Follow with moisturizer.

For first-time users: Test on a small area before full application.

Do Not Use

■ If allergic to salicylic acid or any ingredient.

■ On broken, sunburned, or irritated skin.

■ With other acne medications containing salicylic acid, unless directed by a doctor.

Other Information

■ Storage: Keep container tightly closed at 15-25°C (59-77°F). .

■ Shelf Life: 24 months unopened; discard if pads dry out.

■ Eco-Friendly: Biodegradable cotton pads; recycle outer packaging.

Active Ingredient(s)

Salicylic Acid 2%



Inactive Ingredients

Aqua (Water), Niacinamide, Butylene Glycol, Ethylhexylglycerin, Azelaic Acid, Hamamelis Virginiana (Witch Hazel)Extract,

Sodium Hyaluronate, Panthenol, Acrylates Copolymer, Phenoxyethanol

Package Label Principal Display Panel


Structured Label Content

Use

■ Treats acne and prevents breakouts

■ Removes blackheads and minimizes pores

■ Gently exfoliates dead skin cells

■ Improves skin texture and tone

Section 50565-1 (50565-1)

Contains salicylic acid; harmful if swallowed.

If ingested, contact Poison Control immediately (U.S.: 1-800-222-1222).



Section 50566-9 (50566-9)

Severe irritation, rash, or peeling develops.

No improvement after 12 weeks of regular use.

Signs of allergic reaction (swelling, itching, dificulty breathing). .



Section 50567-7 (50567-7)

■ Mild tingling or redness may occur initially (discontinue if severe).

■ Avoid sun exposure after use; apply sunscreen daily.

■ Do not combine with harsh scrubs or alcohol-based products.

■ Keep away from eyes and mucous membranes.

Purpose

Acne treatment



Warnings

Do not use on injured wounds

Directions

■ Cleanse and dry face thoroughly.

■ Gently wipe the pad over affected areas (avoid eye contour).

■ Use once daily (evening recommended) for normal skin, or every other day for sensitive skin.

■ Follow with moisturizer.

For first-time users: Test on a small area before full application.

Do Not Use (Do not use)

■ If allergic to salicylic acid or any ingredient.

■ On broken, sunburned, or irritated skin.

■ With other acne medications containing salicylic acid, unless directed by a doctor.

Other Information (Other information)

■ Storage: Keep container tightly closed at 15-25°C (59-77°F). .

■ Shelf Life: 24 months unopened; discard if pads dry out.

■ Eco-Friendly: Biodegradable cotton pads; recycle outer packaging.

Active Ingredient(s)

Salicylic Acid 2%



Inactive Ingredients (Inactive ingredients)

Aqua (Water), Niacinamide, Butylene Glycol, Ethylhexylglycerin, Azelaic Acid, Hamamelis Virginiana (Witch Hazel)Extract,

Sodium Hyaluronate, Panthenol, Acrylates Copolymer, Phenoxyethanol

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


Advanced Ingredient Data


Raw Label Data

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