MARK.  BREAK OUT PLAN- salicylic acid gel 
Avon Products Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

See attached 1092906 breakout plan FC.jpg


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

Uses


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. 


Directions

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? Call 1-800-meetmark

image of carton label
MARK.   BREAK OUT PLAN
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0195
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.75 mL  in 50 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10096-0195-150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33312/29/2009
Labeler - Avon Products Inc. (001468693)
Establishment
NameAddressID/FEIBusiness Operations
Avon products, Inc.005149471manufacture

Revised: 12/2009
Document Id: 42816e46-aaec-483d-8e12-2a01051bf501
Set id: 987932c4-e880-40c1-92e1-55fada880a2c
Version: 1
Effective Time: 20091229
 
Avon Products Inc.