SPL v2
SPL
SPL Set ID 41ac6e4e-59ad-6d80-e063-6394a90adc01
Route
TOPICAL
Published
Effective Date 2021-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Water Alpha-tocopherol Acetate Polysorbate 20 Peg-20 Methyl Glucose Sesquistearate Methyl Glucose Sesquistearate Phenoxyethanol Xanthan Gum Cetostearyl Alcohol Peg-100 Stearate Niacinamide Retinol Edetate Disodium Sodium Benzoate Alcohol Citrulline Carbomer Homopolymer, Unspecified Type Methyl Gluceth-20 Sodium Hydroxide Glyceryl Stearate Se Potassium Sorbate Glycerin Dicaprylyl Ether Arginine Citric Acid Monohydrate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-11

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 evening.

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 stated above.

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, Dicaprylyl Ether, Niacinamide, Citrulline, Arginine, Methyl Gluceth-20, Cetearyl Alcohol, Carbomer, Xanthan Gum, Tocopheryl Acetate, Retinol, Citric Acid, Sodium Hydroxide, Disodium EDTA, PEG-20 Methyl Glucose Sesquistearate, PEG-100 Stearate, Glyceryl Stearate, Methyl Glucose Sesquistearate, Polysorbate 20, 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 evening.

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 stated above.

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, Dicaprylyl Ether, Niacinamide, Citrulline, Arginine, Methyl Gluceth-20, Cetearyl Alcohol, Carbomer, Xanthan Gum, Tocopheryl Acetate, Retinol, Citric Acid, Sodium Hydroxide, Disodium EDTA, PEG-20 Methyl Glucose Sesquistearate, PEG-100 Stearate, Glyceryl Stearate, Methyl Glucose Sesquistearate, Polysorbate 20, 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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