SPL v2
SPL
SPL Set ID a8a80ae6-3273-45d7-a143-4243056913df
Route
TOPICAL
Published
Effective Date 2010-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (.5 mL)
Inactive Ingredients
Water Squalane Propylene Glycol Cetyl Alcohol Glycerin Glycol Stearate Dimethicone Methylparaben Propylparaben Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-06-01

Description

Drug Facts

Purpose

Acne Treatment


Medication Information

Warnings and Precautions

For external use only.

Purpose



Acne Treatment

Description

Drug Facts

Use

for the treatment of acne.

Section 42229-5
Drug Facts
Section 50565-1

Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if condition persists or gets worse.

Section 50567-7

When using this product

  • do not get into eyes or mucous membranes
  • use only in a well-ventilated area
Section 50568-5

Ask a doctor before use if you have deep puncture wounds or serious burns

Section 50570-1

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

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 occurs, reduce application to once a day.

Package Label

Enter section text here

Active Ingredient


Salicylic Acid  0.5%
Other Information

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

Inactive Ingredients

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


Structured Label Content

Use

for the treatment of acne.

Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)

Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition persists or gets worse.

Section 50567-7 (50567-7)

When using this product

  • do not get into eyes or mucous membranes
  • use only in a well-ventilated area
Section 50568-5 (50568-5)

Ask a doctor before use if you have deep puncture wounds or serious burns

Section 50570-1 (50570-1)

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

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 occurs, reduce application to once a day.

Package Label

Enter section text here

Active Ingredient


Salicylic Acid  0.5%
Other Information (Other information)

store between 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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)