SPL v2
SPL
SPL Set ID 21ea9a55-0a1f-47f7-e063-6294a90aa269
Route
TOPICAL
Published
Effective Date 2022-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Phenoxyethanol Lactic Acid Tetrapeptide-21 Butylene Glycol Ppg-26-buteth-26 Deanol Edetate Disodium Citrulline Zinc Gluconate Magnesium Aspartate Hyaluronate Sodium Water Succinic Acid Copper Gluconate Acetyl L-tyrosine Alcohol Polyoxyl 40 Hydrogenated Castor Oil Glycerin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-04
Description

Salicylic Acid 2.0%

Medication Information

Warnings and Precautions

For external use only.

Keep out of eyes. If product enters the eyes, wash out thoroughly with warm water.

Indications and Usage

For the treatment of acne.

Dosage and Administration

■ Clean the skin thoroughly before applying this product. ■ Cover the entire affected area with a thin layer morning & evening. No rinsing is needed. Wait until dry before applying treatment or moisturizer. ■ Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. ■ If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Description

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 50567-7

When Using This Product ■ skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

Section 51727-6

Water/Aqua/Eau, SD Alcohol 40-B, Dimethyl MEA, Phenoxyethanol, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Disodium EDTA, Glycerin, Magnesium Aspartate, Zinc Gluconate, Lactic Acid, Acetyl Tyrosine, Succinic Acid, Citrulline, Butylene Glycol, Copper Gluconate, Sodium Hyaluronate, Tetrapeptide-21

Section 51945-4

Section 53413-1

1-888-823-7837

Section 55105-1

Acne Treatment

Section 55106-9

Salicylic Acid 2.0%

Structured Label Content

Indications and Usage (34067-9)

For the treatment of acne.

Dosage and Administration (34068-7)

■ Clean the skin thoroughly before applying this product. ■ Cover the entire affected area with a thin layer morning & evening. No rinsing is needed. Wait until dry before applying treatment or moisturizer. ■ Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. ■ If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Warnings and Precautions (34071-1)

For external use only.

Keep out of eyes. If product enters the eyes, wash out thoroughly with warm water.

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 50567-7 (50567-7)

When Using This Product ■ skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

Section 51727-6 (51727-6)

Water/Aqua/Eau, SD Alcohol 40-B, Dimethyl MEA, Phenoxyethanol, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Disodium EDTA, Glycerin, Magnesium Aspartate, Zinc Gluconate, Lactic Acid, Acetyl Tyrosine, Succinic Acid, Citrulline, Butylene Glycol, Copper Gluconate, Sodium Hyaluronate, Tetrapeptide-21

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-888-823-7837

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Salicylic Acid 2.0%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:51.072093 · Updated: 2026-03-14T23:13:16.476899