Mark.
FDA Label NDC 10096-0195

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avon Products Inc. for the product Mark. (NDC 10096-0195). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - when using, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - 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

Otc - When Using

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

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

Otc - Questions

Questions? Call 1-800-meetmark

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