SPL v1
SPL
SPL Set ID 528e48cb-9f36-4717-896c-0bae3d997e6e
Route
TOPICAL
Published
Effective Date 2016-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Yellow Wax Butylated Hydroxytoluene Benzoic Acid Petrolatum Polysorbate 80 Sulfur Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-02-10

Description

Active Ingredients: Salicylic Acid 2%


Medication Information

Warnings and Precautions

Warnings:

*For external use only.

*Avoid contact with eyes. If contact occurs, rinse thoroughly with water

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 only topical acne medication at a time

*Do not use without consulting a doctor if the condition appears over a large portion of the body.

Store at room temperature.

Indications and Usage

For Skin Acne treatment

For relief, irritation, redness and of Acne

Indications:

*For the treatment of Acne.  Clears up acne pimples and blemishes, and allows skin to heal. Helpsprevent new pimples and blemishes from forming.

Dosage and Administration

Directions:

*Clean the skin thoroughly before applying this product.

*Cover the entire affected area with a thing layer one to three times daily, then gradually increase to two or three time 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

Active Ingredients: Salicylic Acid 2%

Section 50565-1

Keep out of reach of children. If swallowed, contact physician or poison control center immediately.

Section 51727-6

Other Ingredients: beeswax, BHT, benzoic acid, petrolatum, polysorbate 80, sulfur, zinc oxide.

Section 51945-4

Section 55105-1

Acne Treatment

Section 55106-9

Active Ingredients:

Salicylic Acid 2%


Structured Label Content

Indications and Usage (34067-9)

For Skin Acne treatment

For relief, irritation, redness and of Acne

Indications:

*For the treatment of Acne.  Clears up acne pimples and blemishes, and allows skin to heal. Helpsprevent new pimples and blemishes from forming.

Dosage and Administration (34068-7)

Directions:

*Clean the skin thoroughly before applying this product.

*Cover the entire affected area with a thing layer one to three times daily, then gradually increase to two or three time 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

Warnings and Precautions (34071-1)

Warnings:

*For external use only.

*Avoid contact with eyes. If contact occurs, rinse thoroughly with water

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 only topical acne medication at a time

*Do not use without consulting a doctor if the condition appears over a large portion of the body.

Store at room temperature.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, contact physician or poison control center immediately.

Section 51727-6 (51727-6)

Other Ingredients: beeswax, BHT, benzoic acid, petrolatum, polysorbate 80, sulfur, zinc oxide.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Active Ingredients:

Salicylic Acid 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)