Monat Be Clarified Acne-clearing Moisturizer Lotion
FDA Label NDC 68577-107

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa, Corporation for the product Monat Be Clarified Acne-clearing Moisturizer (NDC 68577-107). 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 drug facts, active ingredient, purpose, uses, warnings, when using this product, stop use and consult with a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Salicylic Acid 2.00%

Purpose

Acne Treatment

Uses

  • For the treatment of acne
  • Helps prevent new acne blemishes from forming

Warnings

For external use only.

When Using This Product

  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time.
    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use And Consult With A Doctor If

irritation becomes severe.

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a poison control center immediately.

Directions

  • Clean skin thoroughly before applying this product.
  • Apply a dime-sized amounth onto fingers. Gently use fingertips to apply to clean and dry face using circular motions.
  • Cover the entire affected area with a thin layer one to three times daily.
  • 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 or every other day.

Inactive Ingredients

Water, Dimethyl Isosorbide, Glycerin, Sodium Hydroxide, Cetearyl Olivate, Caprylic/Capric Triglyceride, Lactococcus Ferment Lysate, Niacinamide, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Sorbitan Isostearate, Polysorbate 60, Polyacrylate Crosspolymer-6, Sorbitan Olivate, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol, Coco-Caprylate/Caprate, Triheptanoin, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Physalis Angulata Extract, Lactic Acid, Sodium Hyaluronate, 1,2-Hexanediol, Polylysine, Camellia Sinensis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Bisabolol, Pentylene Glycol, Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Sodium Chloride, t-Butyl Alcohol, Chlorphenesin, Phenylpropanol, Levulinic Acid, Sodium Levulinate

Questions Or Comments?

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