SPL v1
SPL
SPL Set ID 0863929c-3a29-576c-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2014-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Sodium Cetostearyl Sulfate Potassium Sorbate Glycyrrhiza Glabra Bergamot Oil Salix Alba Bark Water Glycerin Aloe Vera Leaf Orange Oil Propanediol Medium-chain Triglycerides C14-22 Alcohols Peppermint Oil Hamamelis Virginiana Top Water Parsley Chamomile Melissa Officinalis Leaf C12-20 Alkyl Glucoside Cetostearyl Alcohol Anhydrous Citric Acid Potassium Hydroxide Xanthan Gum Benzoic Acid Phenoxyethanol Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-11-26

Description

Active Ingredient Salicylic Acid 2.0%


Medication Information

Warnings and Precautions

For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water.

Indications and Usage

For the treatment of acne.

Dosage and Administration

Wipe face and neck to remove makeup, oil, grime and other pore clogging impurities. Avoid eye area. Do not rinse. Because drying of the skin may occur, start with one application daily and gadually increase to two or three times daily if needed or directed by doctor. If bothersome dryness or peeling occurs, reduce frequency of application.

Description

Active Ingredient Salicylic Acid 2.0%

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

Section 51727-6

Water, Propanediol, Caprylic/Capric Triglyceride, C14-22 Alcohols, Sodium Cetearyl Sulfate, Aloe Barbadensis Leaf Juice(1), Hamamelis Verginiana (Witch Hazel) Water, Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Carum Petroselinum (Parsley) Extract, Glycyrrhiza Glabra (Licorice) Roo Exxtract, Salix Alba (Willow) Bark Extract (1),Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Aurantium Bergamia (Bergamot) Oil (2), Mentha Piperita (Peppermint) Oil (2), C12-20 Alkyl Glucoside, Cetearyl Alcohol, Citric Acid, Glycerin, Potassium Hydroxude, Xanthan Gum, Benzoic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organicf Ingredient; (2) For scent only

Section 51945-4

Section 55105-1

Acne Treatment

Section 55106-9

Active Ingredient

Salicylic Acid 2.0%


Structured Label Content

Indications and Usage (34067-9)

For the treatment of acne.

Dosage and Administration (34068-7)

Wipe face and neck to remove makeup, oil, grime and other pore clogging impurities. Avoid eye area. Do not rinse. Because drying of the skin may occur, start with one application daily and gadually increase to two or three times daily if needed or directed by doctor. If bothersome dryness or peeling occurs, reduce frequency of application.

Warnings and Precautions (34071-1)

For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

Section 51727-6 (51727-6)

Water, Propanediol, Caprylic/Capric Triglyceride, C14-22 Alcohols, Sodium Cetearyl Sulfate, Aloe Barbadensis Leaf Juice(1), Hamamelis Verginiana (Witch Hazel) Water, Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Carum Petroselinum (Parsley) Extract, Glycyrrhiza Glabra (Licorice) Roo Exxtract, Salix Alba (Willow) Bark Extract (1),Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Aurantium Bergamia (Bergamot) Oil (2), Mentha Piperita (Peppermint) Oil (2), C12-20 Alkyl Glucoside, Cetearyl Alcohol, Citric Acid, Glycerin, Potassium Hydroxude, Xanthan Gum, Benzoic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organicf Ingredient; (2) For scent only

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient

Salicylic Acid 2.0%


Advanced Ingredient Data


Raw Label Data

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