SPL v1
SPL
SPL Set ID ac4aa8e2-dff9-4706-8bb6-711045aa5433
Route
TOPICAL
Published
Effective Date 2016-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (.5 g)
Inactive Ingredients
Water Propylene Glycol Polysorbate 20 Polyoxyl 40 Hydrogenated Castor Oil Dmdm Hydantoin Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-07-20

Description

Active ingredient Salicylic Acid 0.5%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Ask a doctor or pharmacist before use if you ar eusing other topical acne

medications at the same time or immediately following use of this product.

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 one topical acne medication at a time.

-avoid contact with eyes. If contact occurs, flush thoroughly with water.

Indications and Usage

Use  for the treatment of acne

Dosage and Administration

Directions

-use daily to get clear skin.

-clean the skin thoroughly before applying this product.

-cover the entire affected area one to three times daily.

-because excessive drying of the skinmay 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.

-throw away cloth (do not flush).

Description

Active ingredient Salicylic Acid 0.5%

Section 44425-7

Other information   store at room temperature.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact

a Poison Control Center right away.

Section 51727-6

Inactive ingredients

Water, Propylene Glycol, Polysorbate 20,

PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin,

Kinginka Ekisu, Iodopropynol Butylcarbamate, Frangrance

Section 51945-4

Section 55105-1

Purpose

Acne Treatment

Section 55106-9

Active ingredient

Salicylic Acid 0.5%


Structured Label Content

Indications and Usage (34067-9)

Use  for the treatment of acne

Dosage and Administration (34068-7)

Directions

-use daily to get clear skin.

-clean the skin thoroughly before applying this product.

-cover the entire affected area one to three times daily.

-because excessive drying of the skinmay 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.

-throw away cloth (do not flush).

Warnings and Precautions (34071-1)

Warnings

For external use only.

Ask a doctor or pharmacist before use if you ar eusing other topical acne

medications at the same time or immediately following use of this product.

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 one topical acne medication at a time.

-avoid contact with eyes. If contact occurs, flush thoroughly with water.

Section 44425-7 (44425-7)

Other information   store at room temperature.

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 51727-6 (51727-6)

Inactive ingredients

Water, Propylene Glycol, Polysorbate 20,

PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin,

Kinginka Ekisu, Iodopropynol Butylcarbamate, Frangrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Acne Treatment

Section 55106-9 (55106-9)

Active ingredient

Salicylic Acid 0.5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)