MARK.- salicylic acid gel

MARK. by

Drug Labeling and Warnings

MARK. by is a Otc medication manufactured, distributed, or labeled by Avon Products Inc., Avon products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

See attached 1092906 breakout plan FC.jpg

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

INDICATIONS & USAGE

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

Warnings
For external use only

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.

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

DOSAGE & ADMINISTRATION

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

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

QUESTIONS

Questions? Call 1-800-meetmark

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MARK.   BREAK OUT PLAN
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0195
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	.75 mL  in 50 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0195-1	50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	12/29/2009

Labeler - Avon Products Inc. (001468693)

Establishment
Name	Address	ID/FEI	Business Operations
Avon products, Inc.		005149471	manufacture