21ea9a55-0a1f-47f7-e063-6294a90aa269

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.

Active Ingredient

Salicylic Acid 2.0%

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


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

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

Active Ingredient (55106-9)

Salicylic Acid 2.0%

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.

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


Advanced Ingredient Data


Raw Label Data

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