Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 764fa818-4412-490e-af6f-2cccb8736cc7
Route
TOPICAL
Published
Effective Date 2024-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Alcohol Dimethicone Betaine 1,2-hexanediol Mandelic Acid Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Dehydroxanthan Gum Phenoxyethanol Ammonia Tert-butyl Alcohol Denatonium Benzoate Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-15

Description

Salicylic acid 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 2%

Use

for the treatment of acne

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 irritation becomes severe.

Section 50567-7

When using this product: skin irritation and dryness are 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 unless directed by a doctor. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Avoid unnecessary sun exposure and use a sunscreen of SPF15 or higher.

Section 50570-1

Do not use if you have very sensitive skin or are sensitive to salicylic acid.

Warnings

For external use only

Directions:

Sensitivity test for a new user: apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow these directions: cover the entire affected area with a thin layer one to three times daily. Do not rinse off. Because excessive drying or skin irritation may occur, start with one application daily, then gradually increase to two to three times daily if needed or directed by a doctor. If bothersome dryness, peeling or irritation occurs, reduce application to once a day or every other day.

Active Ingredient

Salicylic acid 2%

Inactive Ingredients:

WATER, ALCOHOL, DIMETHICONE, BETAINE, 1,2-HEXANEDIOL, MANDELIC ACID, POLYACRYLATE CROSSROLYMER-6,DEHYDROXANTHAN GUM, PHENOXYETHANOL, AMMONIA, T-BUTYL ALCOHOL, DENATONIUM BENZOATE, BLUE 1 (CL 42090)

Principal Display Panel – Bottle Label.

neutralyze®

NEUTRALYZE CLEARING SERUM

SKIN REPAIRING

ACNE TREATMENT GEL

STEP 2 – REPAIR

CLEARS ACNE, FADES DARK SPOTS

& CORRECTS UNEVEN SKIN TONE

CONTROLS OIL, UNCLOGS &

REDUCES THE SIZE OF PORES

1.52 FL. OZ./45 mL


Structured Label Content

Use

for the treatment of acne

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 irritation becomes severe.

Section 50567-7 (50567-7)

When using this product: skin irritation and dryness are 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 unless directed by a doctor. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Avoid unnecessary sun exposure and use a sunscreen of SPF15 or higher.

Section 50570-1 (50570-1)

Do not use if you have very sensitive skin or are sensitive to salicylic acid.

Purpose

Acne treatment

Warnings

For external use only

Directions:

Sensitivity test for a new user: apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow these directions: cover the entire affected area with a thin layer one to three times daily. Do not rinse off. Because excessive drying or skin irritation may occur, start with one application daily, then gradually increase to two to three times daily if needed or directed by a doctor. If bothersome dryness, peeling or irritation occurs, reduce application to once a day or every other day.

Active Ingredient

Salicylic acid 2%

Inactive Ingredients:

WATER, ALCOHOL, DIMETHICONE, BETAINE, 1,2-HEXANEDIOL, MANDELIC ACID, POLYACRYLATE CROSSROLYMER-6,DEHYDROXANTHAN GUM, PHENOXYETHANOL, AMMONIA, T-BUTYL ALCOHOL, DENATONIUM BENZOATE, BLUE 1 (CL 42090)

Principal Display Panel – Bottle Label.

neutralyze®

NEUTRALYZE CLEARING SERUM

SKIN REPAIRING

ACNE TREATMENT GEL

STEP 2 – REPAIR

CLEARS ACNE, FADES DARK SPOTS

& CORRECTS UNEVEN SKIN TONE

CONTROLS OIL, UNCLOGS &

REDUCES THE SIZE OF PORES

1.52 FL. OZ./45 mL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)