Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 47d3c57c-d6d2-a9e0-e063-6294a90a3b5b
Route
TOPICAL
Published
Effective Date 2026-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Lactic Acid Kojic Acid Sugarcane Mandelic Acid Acer Saccharum Bark/sap Water Vaccinium Corymbosum (blueberry) Fruit Bilberry White Mulberry Lemon Sodium Hydroxide Hibiscus Sabdariffa Flower Alcohol Glycerin Phenoxyethanol Aloe Barbadensis Leaf Juice Orange Ethylhexylglycerin Phytic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-07
Description

Active Ingredient: Salicylic Acid 2.0%

Medication Information

Warnings and Precautions



Warnings:

• May cause photosensitivity. Always use SPF. For external use only.

• Overuse of this product will cause dryness.

• Do not use if you have a very sensitive skin.



Indications and Usage



Uses:

For the treatment of acne.



Dosage and Administration



Directions:

• Twice weekly at night, gently swipe treatment pad over clean skin. Allow to fully absorb. If irritation persists, consult your skincare professional. For best results, follow with B5 Moisture Matte.



Description

Active Ingredient: Salicylic Acid 2.0%

Section 50565-1



Keep out of reach of children:

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



Section 50566-9



Stop use and ask a doctor:

• If severe skin irritation occurs.

• Using other topical medication at the same time.



Section 50567-7



When using this product

• Avoid contact with the eyes, lips, and mouth.

• Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

• If sensitive to the sun or when increased sun exposure is expected use a sunscreen.



Section 50570-1

Do not use if you have a very sensitive skin.

Section 51727-6

Inactive ingredients:

Water (Aqua), SD Alcohol 40-B, Lactic Acid, Aloe Barbadensis Leaf Juice, Glycerin, Sodium Hydroxide, Hibiscus Sabdariffa Flower Extract, Kojic Acid, Ethylhexylglycerin, Vaccinium Myrtillus (Bilberry) Extract, Saccharum Officinarum (Sugar Cane) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Acer Saccharum (Sugar Maple) Extract, Vaccinium Corymbosum (Blueberry) Fruit Extract, Morus Alba Fruit Extract, Mandelic Acid, Phytic Acid, Phenoxyethanol

Section 51945-4

Section 55105-1

Purpose:Acne Treatment

Section 55106-9

Active Ingredient: Salicylic Acid 2.0%

Section 60561-8

N/A

Structured Label Content

Indications and Usage (34067-9)



Uses:

For the treatment of acne.



Dosage and Administration (34068-7)



Directions:

• Twice weekly at night, gently swipe treatment pad over clean skin. Allow to fully absorb. If irritation persists, consult your skincare professional. For best results, follow with B5 Moisture Matte.



Warnings and Precautions (34071-1)



Warnings:

• May cause photosensitivity. Always use SPF. For external use only.

• Overuse of this product will cause dryness.

• Do not use if you have a very sensitive skin.



Section 50565-1 (50565-1)



Keep out of reach of children:

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



Section 50566-9 (50566-9)



Stop use and ask a doctor:

• If severe skin irritation occurs.

• Using other topical medication at the same time.



Section 50567-7 (50567-7)



When using this product

• Avoid contact with the eyes, lips, and mouth.

• Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

• If sensitive to the sun or when increased sun exposure is expected use a sunscreen.



Section 50570-1 (50570-1)

Do not use if you have a very sensitive skin.

Section 51727-6 (51727-6)

Inactive ingredients:

Water (Aqua), SD Alcohol 40-B, Lactic Acid, Aloe Barbadensis Leaf Juice, Glycerin, Sodium Hydroxide, Hibiscus Sabdariffa Flower Extract, Kojic Acid, Ethylhexylglycerin, Vaccinium Myrtillus (Bilberry) Extract, Saccharum Officinarum (Sugar Cane) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Acer Saccharum (Sugar Maple) Extract, Vaccinium Corymbosum (Blueberry) Fruit Extract, Morus Alba Fruit Extract, Mandelic Acid, Phytic Acid, Phenoxyethanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient: Salicylic Acid 2.0%

Section 60561-8 (60561-8)

N/A

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:08.193737 · Updated: 2026-03-14T23:12:17.704012