Lerosett Botanical Acne Cleanser Gel
FDA Label NDC 84463-507

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gunilla Of Sweden, Inc. for the product Lerosett Botanical Acne Cleanser (NDC 84463-507). 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 ingredients, purpose, uses:, warning, when using this product, stop use and ask 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 Ingredients

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses:

  • For treatment of acne
  • Penetrates pores to clear most acne blemishes
  • Helps keep skin clear of new acne pimples, blackheads, or whiteheads

Warning

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 or immediately following use of this product. If this occurs, use only one topical acne medication at a time.

Stop Use And Ask A Doctor If

  • irritation becomes severe.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions:

  • Wet the skin and apply the medication to the areas to be cleansed. cover the entire affected area with a thin layer one to three times daily. Massage gently into the skin working it into a full lather. Rinse thoroughly with plain water. Pat the skin dry.
  •  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.
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor

Other Information

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Citrus Limon (Lemon) Oil, Cocamidopropyl Betaine, Coco-Glucoside, Glycerin, Glyceryl Caprylate, Glyceryl Oleate, Glyceryl, Undecylenate, Lauryl Glucoside, Sodium Citrate, Sodium Lauryl Glucose Carboxylate.

Questions Or Comments?

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