FDA Label for Leader Maximum Strength Invisible Acne

View Indications, Usage & Precautions

Leader Maximum Strength Invisible Acne Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Benzoyl Peroxide 10%


Purpose



Acne treatment cream


Uses



  • treats acne
  • dries up acne pimples
  • helps prevent new acne pimples

Warnings



For external use only


Do Not Use



  • on broken skin
  • on large areas of the body
  • if you have sensitive skin or are sensitive to benzoly peroxide

When Using This Product



  • apply to affected ares only
  • avoid unnecessary sun exposure and use a sunscreen
  • do not use in or near eyes
  • this product may bleach hair or dyed fabrics
  • with other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. Only one medication should be used unlee directed by a physician
  • skin irritaion may occur characterized by redness, burning, itching, peeling or possible swelling

Stop And Ask A Doctor If



  • too much irritation or sensitiveity develops or increases

Keep Out Of Reach Of Children



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


Directions



  • cleanse the skin thoroughly before applying
  • cover the entire affected area with a thin layer 1 to 3 times daily
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application ot once a day or every other day.
  • if going outside, use a sunscreen. Allow benzoyl peroxide to dry, then follow directions in the sunscreen labeling.

Other Information



  • keep tightly closed
  • keep away from heat

Inactive Ingredients



Aluminum heydroxide gel, Carbomer 940, Glyceryl monostearate, Isopropyl myristate, Magnesium aluminum silicate, Methylparaben, PEG 12, Propylene glycol, Propylparaben, Purified water


* Please review the disclaimer below.