Label at a glance#

ProductMARK. Break Out Plan

Active ingredientSALICYLIC ACID

Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

See attached 1092906 breakout plan FC.jpg

Active ingredient Purpose
Salicylic Acid 1.5%....................................Acne Treatment

INDICATIONS & USAGE SECTION

Uses

helps in the treatment of acne
helps prevent new acne blemishes from forming
clears up acne blemishes
penetrates pores to eliminate most blackheads and acne pimples

WARNINGS SECTION

Warnings
For external use only

OTC - WHEN USING SECTION

When using this product

avoid contact with eyes. If product contacts eyes, rinse thoroughly with water. If irritation persists, seek medical attention
using other topical acne products at the same time or immediately after use of this product may increase dryness or irritation of the skin. If this occurs, only one product 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.

DOSAGE & ADMINISTRATION SECTION

Directions

cleanse skin thoroughly before applying medication
because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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

INACTIVE INGREDIENT SECTION

Inactive/Non-medicinal ingredients

WATER/EAU
     SD ALCOHOL 40-B
     DIMETHICONE
     POLYSORBATE 20
     GLYCERIN
     PYRUS MALUS (APPLE) FRUIT EXTRACT
     VANILLA PLANIFOLIA FRUIT EXTRACT
     ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT
     MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT
     SPIRAEA ULMARIA EXTRACT
     CINNAMOMUM CASSIA BARK EXTRACT
     CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT
     HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
     ISOHEXADECANE
     XANTHAN GUM
     TRIMETHYLSILOXYSILICATE
     POLYMETHYL METHACRYLATE
     SILICA
     POLYSORBATE 60
     TALC
     SORBITAN ISOSTEARATE
     CAPRYLIC/CAPRIC TRIGLYCERIDE
     ISOPROPYL MYRISTATE
     DIPROPYLENE GLYCOL
     PYRIDOXINE HCL
     DISODIUM EDTA
     BENZYL ALCOHOL

OTC - QUESTIONS SECTION

Questions? Call 1-800-meetmark

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
416212	salicylic acid 1.5 % Topical Gel	PSN	1
416212	salicylic acid 0.015 MG/MG Topical Gel	SCD	1
416212	salicylic acid 1.5 % Topical Gel	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10096-0195-1	2019-10-21	C162847	48780-1	956f9ecf-c8c1-621f-e053-dbdaa90a74ad	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10096-0195-1	MARK. Break Out Plan	50 mL in 1 JAR	GEL	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10096-0195	MARK. (SALICYLIC ACID) GEL [AVON PRODUCTS INC.]	1	Legacy NDC, 1 package rows	20100327_987932c4-e880-40c1-92e1-55fada880a2c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

MARK. Break Out Plan
Salicylic Acid

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10096-0195	10096-0195-1

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
SALICYLIC ACID	O414PZ4LPZ	ACTIB

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
42816e46-aaec-483d-8e12-2a01051bf501			987932c4-e880-40c1-92e1-55fada880a2c	2009-12-29	Warnings	Exact identifier spl id: 42816e46-aaec-483d-8e12-2a01051bf501 spl set id: 987932c4-e880-40c1-92e1-55fada880a2c

Reported adverse events (FAERS/openFDA)#

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

DRUG FACTS