11e15eef-240b-40cf-b644-4f23b606a640

SPL v3
SPL
SPL Set ID 11e15eef-240b-40cf-b644-4f23b606a640
Route
topical
Published
Effective Date 2014-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (14 g)
Inactive Ingredients
dimethicone

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2013-01-01

Purpose

Acne Treatment

Description

Salicylic Acid 0.5%


Medication Information

Warnings and Precautions

Warnings

Uses

for the treatment of acne

Purpose

Acne Treatment

Directions

Cleanse the skin thoroughly before applying medication. Apply cream directly on acne pimples. 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.

Other Information

store at 20 to 25 C (66 to 77 F)

Inactive Ingredients

carbomer, cetyl alcohol, dimethicone, glycerin, glycol stearate, methylparaben, propylene glycol, propylparaben, squalane, triethanolamine, water

Description

Salicylic Acid 0.5%

Section 42229-5

For external use only.

Section 50565-1

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

Section 50566-9

Do not use if you have very sensitive skin or are sensitive to Salicylic Acid

Section 50568-5

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Section 51945-4

Enter section text here

Active Ingredient

Salicylic Acid 0.5%


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Uses

for the treatment of acne

Purpose

Acne Treatment

Directions

Cleanse the skin thoroughly before applying medication. Apply cream directly on acne pimples. 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.

Other Information (Other information)

store at 20 to 25 C (66 to 77 F)

Inactive Ingredients (Inactive ingredients)

carbomer, cetyl alcohol, dimethicone, glycerin, glycol stearate, methylparaben, propylene glycol, propylparaben, squalane, triethanolamine, water

Section 42229-5 (42229-5)

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 50566-9 (50566-9)

Do not use if you have very sensitive skin or are sensitive to Salicylic Acid

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Section 51945-4 (51945-4)

Enter section text here

Active Ingredient (Active ingredient)

Salicylic Acid 0.5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)