SPL v2
SPL
SPL Set ID 21eafafe-18ea-08d3-e063-6294a90abb85
Route
TOPICAL
Published
Effective Date 2018-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Polysorbate 20 Phenoxyethanol Succinic Acid Sodium Benzoate C12-15 Alkyl Lactate C13-14 Isoparaffin Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Lactic Acid Laureth-7 Citrulline Squalane Alcohol Glycerin Dimethicone Water Polyacrylamide (crosslinked; 2 Mole Percent Bisacrylamide) Potassium Sorbate Pvp

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-12

Description

Salicylic Acid 0.5%


Medication Information

Warnings and Precautions
  • For external use only
Indications and Usage

■ For the treatment of acne

Dosage and Administration

Directions ■ Shake well. Apply a thin, even layer to skin in the morning.

For best results, use after cleansing with ACNE RELIEF

Gentle & Soothing Cleanser.

■ Clean the skin thoroughly before applying this product. ■ Cover the entire affected area with a thin layer one to three

times daily.

■ 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.

■ 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 the directions sta

Description

Salicylic Acid 0.5%

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 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

Section 51727-6

Water/Aqua/Eau, SD Alcohol 40-B, Glycerin, C12-15 Alkyl Lactate, PVP, Dimethicone, Polysorbate 20, Citrulline, Squalane, Lactic Acid, Succinic Acid, Polyacrylamide, Dimethicone/Vinyl Dimethicone Crosspolymer, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

Section 51945-4

Section 53413-1

1-888-823-7837

Section 55105-1

Acne Treatment

Section 55106-9

Salicylic Acid 0.5%


Structured Label Content

Indications and Usage (34067-9)

■ For the treatment of acne

Dosage and Administration (34068-7)

Directions ■ Shake well. Apply a thin, even layer to skin in the morning.

For best results, use after cleansing with ACNE RELIEF

Gentle & Soothing Cleanser.

■ Clean the skin thoroughly before applying this product. ■ Cover the entire affected area with a thin layer one to three

times daily.

■ 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.

■ 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 the directions sta

Warnings and Precautions (34071-1)
  • For external use only
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 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

Section 51727-6 (51727-6)

Water/Aqua/Eau, SD Alcohol 40-B, Glycerin, C12-15 Alkyl Lactate, PVP, Dimethicone, Polysorbate 20, Citrulline, Squalane, Lactic Acid, Succinic Acid, Polyacrylamide, Dimethicone/Vinyl Dimethicone Crosspolymer, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

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 0.5%


Advanced Ingredient Data


Raw Label Data

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