NDC 14222-2120 Unblemish Dual Intensive Acne Treatment

Benzoyl Peroxide

NDC Product Code 14222-2120

NDC Code: 14222-2120

Proprietary Name: Unblemish Dual Intensive 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.

Non-Proprietary Name: Benzoyl Peroxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 14222 - Rodan & Fields
    • 14222-2120 - Unblemish Dual Intensive Acne Treatment

NDC 14222-2120-1

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 45 mL in 1 BOTTLE, PUMP

NDC Product Information

Unblemish Dual Intensive Acne Treatment with NDC 14222-2120 is a a human over the counter drug product labeled by Rodan & Fields. The generic name of Unblemish Dual Intensive Acne Treatment is benzoyl peroxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Rodan & Fields

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Unblemish Dual Intensive Acne Treatment Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZOYL PEROXIDE .025 g/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • CERAMIDE 1 (UNII: 5THT33P7X7)
  • CERAMIDE AP (UNII: F1X8L2B00J)
  • CERAMIDE NP (UNII: 4370DF050B)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GERANIOL (UNII: L837108USY)
  • LAURETH-7 (UNII: Z95S6G8201)
  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
  • POMEGRANATE (UNII: 56687D1Z4D)
  • SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Rodan & Fields
Labeler Code: 14222
FDA Application Number: part333D What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-13-2019 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: 12-31-2020 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: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Unblemish Dual Intensive 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

Active Ingredients

Benzoyl Peroxide 2.5%

Purpose

Acne treatment

Uses

  • For the treatment of acne.
  • Helps keep skin clear of new acne blemishes, acne pimples, blackheads, and whiteheads.

Warnings

For external use only

Otc - When Using

  • When using this productSkin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

  • When using this productAvoid unnecessary sun exposure and use a sunscreen
  • Avoid contact with the eyes, lips, and mouth
  • Avoid contact with hair and dyed fabrics, which may be bleached by this product
  • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Otc - Do Not Use

  • Do not use if you
  • Have very sensitive skin.
  • Are sensitive to benzoyl peroxide.

Otc - Stop Use

  • Stop use and ask a doctor ifIrritation becomes severe

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

  • Clean the skin thoroughly before applying this product. Dispense 1-2 pumps from each side. Blend product evenly. Cover the entire affected area with a thin even layer one to three times daily. Do not rinse product off face.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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.
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Wash hands after application to help avoid staining fabrics.

Other Information

Store between 15-30°C (59-86°F).

Inactive Ingredients

Water, Ethoxydiglycol, Glycerin, Polyacrylamide, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Allantoin, Niacinamide, Panthenol, Punica Granatum Fruit Extract, Yucca Glauca Root Extract, Ceramide AP, Ceramide EOP, Ceramide NP, Fragrance (Parfum), Biosaccharide Gum-1, Disodium Cocamido MIPA-Sulfosuccinate, Carbomer, Cholesterol, Leuconostoc/Radish Root Ferment Filtrate, Corn Starch Modified, Phytosphingosine, Sodium Lauroyl Lactylate, Xanthan Gum, Laureth-7, Aminomethyl Propanol, Disodium Oleamido MEA-Sulfosuccinate, Cl3-14 lsoparaffin, PEG-7 Glyceryl Cocoate, BHT, Disodium EDTA, Ethylhexylglycerin, Benzyl Alcohol, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool

Questions

1-888-995-5656

* Please review the disclaimer below.

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