Label at a glance#

ProductACNE

Active ingredientSALICYLIC ACID

Label structure8 sections

Indications and uses

for the treatment of acne

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

for the treatment of acne

WARNINGS SECTION

Warnings

SPL UNCLASSIFIED SECTION

For external use only.

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acne Cream LabelEnter section text here

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0639277924797	GTIN-13: 0639277924797 EAN-13: 0639277924797 GTIN-12: 639277924797 UPC-A: 639277924797 GTIN storage (14 digits): 00639277924797	label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33992-1307-1	2019-11-27	C162847	48780-1	9855e2a2-44b5-60a7-e053-dbdaa90a05bd	11e15eef-240b-40cf-b644-4f23b606a640

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33992-1307-1	ACNE	1 in 1 BOX	CREAM	1		3
33992-1307-1	ACNE	43 g in 1 TUBE	CREAM	43		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33992-1307	ACNE (SALICYLIC ACID) CREAM [GREENBRIER INTERNATIONAL INC]	3	Legacy NDC, 2 package rows	20140721_11e15eef-240b-40cf-b644-4f23b606a640.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

ACNE
SALICYLIC ACID
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
33992-1307	33992-1307-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SALICYLIC ACID	O414PZ4LPZ	ACTIB
DIMETHICONE	92RU3N3Y1O	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8c93f61f-6598-4554-ba46-6ef7c8421a14			11e15eef-240b-40cf-b644-4f23b606a640	2014-07-21	Warnings	Exact identifier spl id: 8c93f61f-6598-4554-ba46-6ef7c8421a14 spl set id: 11e15eef-240b-40cf-b644-4f23b606a640

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.