FDA Label for Winco Foods Maximum Strength Acne Treatment

View Indications, Usage & Precautions

Winco Foods Maximum Strength Acne Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. 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.

Otc - Active Ingredient



Active ingredient                                                                Purpose

Benzoyl peroxide 10%..................................................... Acne medication


Otc - Purpose



Uses

  • For the treatmnet and prevention of acne pimples

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use if you have sensitive skin or are sensitive to benzoyl peroxide


Otc - When Using



When using this product

  • avoid contact with eyes, lips, and mouth
  • avoid contact with hair or dyed fabrics including carpet and clothing which may be bleached by this product
  • with other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. More frequent use or higher concentration may aggravate skin irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration

Otc - Ask Doctor



Stop use and ask a doctor if skin irritation becomes severe


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately


Indications & Usage



Directions

  • cleanse the skin thoroughly before applying medication
  • cover the entire affected area with a thin layer one to three times a day
  • 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
  • use to prevent new pimples from forming

Storage And Handling



Other information

  • keep tightly closed
  • keep away from heat
  • store at 20-25°C (68-77°F)

Inactive Ingredient



Inactive ingredients

aluminum hydroxide, bentonite, dimethicone, glyceryl stearate SE, isopropyl myristate, methylparaben, petrolatum, polyethylene glycol 400, propylene glycol, propylparaben, tefose 63, water


Dosage & Administration



DISTRIBUTED BY:

WINCO FOODS, LLC

BOISE, ID 83704

MADE IN KOREA


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