NDC 67091-195 Winco Foods Maximum Strength Acne Treatment

NDC Product Code 67091-195

NDC CODE: 67091-195

Proprietary Name: Winco Foods Maximum Strength Acne Treatment What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

NDC Code Structure

  • 67091 - Winco Foods, Llc
    • 67091-195 - Winco Foods Maximum Strength Acne Treatment

NDC 67091-195-28

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Winco Foods Maximum Strength Acne Treatment with NDC 67091-195 is a product labeled by Winco Foods, Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 106315.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • BENTONITE (UNII: A3N5ZCN45C)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Winco Foods, Llc
Labeler Code: 67091
Start Marketing Date: 12-01-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Benzoyl Peroxide Topical

Benzoyl Peroxide Topical is pronounced as (ben' zoe il)

Why is benzoyl peroxide topical medication prescribed?
Benzoyl peroxide is used to treat mild to moderate acne....
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Winco Foods Maximum Strength Acne Treatment Product Label Images

Winco Foods Maximum Strength Acne Treatment Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredient                                                                PurposeBenzoyl peroxide 10%..................................................... Acne medication

Otc - Purpose

  • UsesFor the treatmnet and prevention of acne pimples

Warnings

WarningsFor 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 productavoid contact with eyes, lips, and mouthavoid contact with hair or dyed fabrics including carpet and clothing which may be bleached by this productwith 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 doctorskin 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

  • Directionscleanse the skin thoroughly before applying medicationcover the entire affected area with a thin layer one to three times a daybecause 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 dayuse to prevent new pimples from forming

Storage And Handling

  • Other informationkeep tightly closedkeep away from heatstore at 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredientsaluminum 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, LLCBOISE, ID 83704MADE IN KOREA

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