Winco Foods Maximum Strength Acne Treatment
FDA Label NDC 67091-195

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Foods Maximum Strength Acne Treatment (NDC 67091-195). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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