Clearcalm Non-drying Acne Treatment
FDA Label NDC 51417-0005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ren Ltd. for the product Clearcalm Non-drying Acne Treatment (NDC 51417-0005). 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 active ingredient, purpose, use, warnings, when using this product, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Salicylic Acid 0.5%

Purpose

AcneTreatment

Use

  • for the treatment of acne

Warnings

For external use only.

When Using This Product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • clean the skin thoroughly before applying this product.
  • 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 (Aqua), Alcohol Denat.,Glycerin, Xanthan Gum, Maritime Pine Bark Extract, Caprylyl/Capryl Glucoside, Willow Bark Extract, Xylitylglucoside, Anhydroxylitol, Sodium Benzoate, Xylitol, Propanediol, Sandalwood Wood Oil, Potassium Sorbate, Sodium Cocoyl Glutamate, Glucose, Citric Acid, Glyceryl Caprylate, Polyglyceryl-6 Oleate, Thyme Leaf Oil, Chlorella Extract, Sodium Surfactin, Lactic Acid, Sodium Lactate, Farnesol

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