NDC 0023-4965 Skinmedica Acne Treatment

Benzoyl Peroxide

NDC Product Code 0023-4965

NDC 0023-4965-02

Package Description: 1 BOTTLE in 1 CARTON > 56.7 g in 1 BOTTLE

NDC Product Information

Skinmedica Acne Treatment with NDC 0023-4965 is a a human over the counter drug product labeled by Allergan, Inc.. The generic name of Skinmedica Acne Treatment is benzoyl peroxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Allergan, Inc.

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.

Skinmedica 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 25 mg/g

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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
  • HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
  • METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POLYISOBUTYLENE (35000 MW) (UNII: 98553S1MHQ)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SALIX NIGRA BARK (UNII: QU52J3A5B3)
  • SAGE (UNII: 065C5D077J)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Allergan, Inc.
Labeler Code: 0023
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: 01-01-2013 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.

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....
[Read More]

* Please review the disclaimer below.

Skinmedica Acne Treatment Product Label Images

Skinmedica 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

Other

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Use

  • For the treatment of acne
  • Dries up acne pimples. Helps prevent new acne pimples

Warnings

For external use only

Do Not Use If You

  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide

When Using This Product

  • Skin irritation and dryness is most 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
  • Avoid 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

Stop Use And Ask A Doctor If

  • Irritation becomes severe

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions Am/Pm

  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily
  • 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 develops, stop use of both products and ask a doctor
  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above

Other Information

Store at controlled room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients

Water, Methyl Methacrylate/Glycol Dimethylacrylate Crosspolymer, C12-15 Alkyl Benzoate, Polyacrylate-13, Hydroxyphenyl Propamidonezoic Acid, Salix Nigra (Willow) Bark Extract, Hamamelis Virgiana (Witch Hazel) Bark/Leaf/Twig Extract, Salvia Officinalis (Sage) Leaf Extract, Allantoin, Bisabolol, Butylene Glycol, Pentylene Glycol, Xanthan Gum, Polyisobutene, Polysorbate 20, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate

* Please review the disclaimer below.