NDC 0023-4948 Skin Medica Purifying Foaming Wash

Salicylic Acid

NDC Product Code 0023-4948

NDC 0023-4948-05

Package Description: 1 BOTTLE in 1 CARTON > 147.9 mL in 1 BOTTLE

NDC Product Information

Skin Medica Purifying Foaming Wash with NDC 0023-4948 is a a human over the counter drug product labeled by Allergan, Inc.. The generic name of Skin Medica Purifying Foaming Wash is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Allergan, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Skin Medica Purifying Foaming Wash 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.

  • SALICYLIC ACID 20 mg/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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CAMPHOR OIL (UNII: 75IZZ8Y727)
  • COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • MENTHOL (UNII: L7T10EIP3A)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SALIX NIGRA BARK (UNII: QU52J3A5B3)
  • SAGE (UNII: 065C5D077J)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • WATER (UNII: 059QF0KO0R)

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’.

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Information for Patients

Salicylic Acid Topical

Salicylic Acid Topical is pronounced as (sal'' i sil' ik as' id)

Why is salicylic acid topical medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions ...
[Read More]

* Please review the disclaimer below.

Skin Medica Purifying Foaming Wash Product Label Images

Skin Medica Purifying Foaming Wash 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

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.

Active Ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Use

  • For treatment of acne.

Warnings

For external use only.

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.

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 Am/Pm

  • Moisten skin with warm water.
  • Dispense two full pumps of Purifying Foaming Wash into palm of hand, apply by gently massaging over the entire affected area, rinse thoroughly and pat dry.
  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • 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.

Other Information

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

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate,Butylene Glycol, Sodium Methyl Cocoyl Taurate, Cocamidopropylamine Oxide, Salix Nigra (Willow) Bark Extract, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Salvia Officinalis (Sage) Leaf Extract, Allantoin, Panthenol, Menthol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cinnamomum Camphora (Camphor) Bark Oil, Polysorbate 20, Sodium Citrate, Disodium EDTA, Methylisothiazolinone

* Please review the disclaimer below.