NDC 42853-102 All-in-one

NDC Product Code 42853-102

NDC CODE: 42853-102

Proprietary Name: All-in-one 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

  • 42853 - Augustus Biomed Llc

NDC 42853-102-13

Package Description: 100 mL in 1 TUBE

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

NDC Product Information

All-in-one with NDC 42853-102 is a product labeled by Augustus Biomed Llc. The product's dosage form is and is administered via form.

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.

  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • ALOE (UNII: V5VD430YW9)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • ALCOHOL (UNII: 3K9958V90M)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SORBIC ACID (UNII: X045WJ989B)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • WATER (UNII: 059QF0KO0R)
  • ZINC OXIDE (UNII: SOI2LOH54Z)

Product Labeler Information

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

Labeler Name: Augustus Biomed Llc
Labeler Code: 42853
Start Marketing Date: 02-25-2012 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: 12-31-2017 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".

* Please review the disclaimer below.

All-in-one 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 IngredientBenzoyl Peroxide 5% w/v

Otc - Purpose

PurposeAcne treatment

Indications & Usage

Use for the treatment of acne

Warnings

Warnings - For external use only

Otc - Do Not Use

Do not use if you are sensitive to Benzoyl Peroxide or have very sensitive skin.This product may cause irritation. Ask a doctor or pharmacist before use if youare using other topical acne medications at the same time or immediatelyfollowing use of this product. When using this product avoid contact with eyes.If occurs flush thoroughly. Keep away from lips and mouth. Avoid excessive sunexposure. Skin irritation may occur such as redness, burning, itching orswelling. Irritation may be reduced by using less frequently or in a smaller dose.

Otc - Stop Use

Stop use and consult a doctor if irritation becomes severe.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help orcontact a Poison Control Center immediately.

Dosage & Administration

DIRECTIONS• Before each use, wash skin with mild soap and allow to dry.• Apply generously to pimples, brown spots, and aging skin. Use three to four times daily for one to three months for best results.• Use twice daily to prevent acne from reappearing.• Do not use with other acne creams, skin peels and treatments, or exfoliants.• If bothersome irritation, drying, or skin peeling should occur, reduce frequency of use.

Inactive Ingredient

Inactive ingredients: Alkyl Benzoate, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Butylparaben, Diazolidinyl Urea, Ethyl Alcohol, Ethylparaben, Lactic Acid, Methyparaben, Niacinamide, Phenoxyethanol, Propylparaben, Sodium Metabisulfite, Sorbic Acid, Tocopheryl (Vitamin E), Water, Zinc Oxide

Other Safety Information

Other Information • Sensitivity test: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the stated directions.• Avoid contact with hair anddyed fabrics, which may be bleached by this product.

* Please review the disclaimer below.