NDC 44019-006 Acne Wipes

Salicylic Acid

NDC Product Information

Acne Wipes with NDC 44019-006 is a a human over the counter drug product labeled by Yinjing Medical Technology (shanghai) Co., Ltd.. The generic name of Acne Wipes is salicylic acid. The product's dosage form is swab and is administered via topical form.

Labeler Name: Yinjing Medical Technology (shanghai) Co., Ltd.

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

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.

Acne Wipes 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 .5 g/100mL

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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

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.
  • 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: Yinjing Medical Technology (shanghai) Co., Ltd.
Labeler Code: 44019
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: 07-20-2016 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]

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Acne Wipes Product Label Images

Acne Wipes 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 ingredientSalicylic Acid 0.5%

Otc - Purpose

PurposeAcne Treatment

Indications & Usage

Use  for the treatment of acne

Warnings

WarningsFor external use only.Ask a doctor or pharmacist before use if you ar eusing other topical acnemedications at the same time or immediately following use of this product. When using this product-skin 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.-avoid contact with eyes. If contact occurs, flush thoroughly with water.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions-use daily to get clear skin.-clean the skin thoroughly before applying this product.-cover the entire affected area one to three times daily.-because excessive drying of the skinmay occur, start with oneapplication daily, then gradually increase to two or three times dailyif needed or as directed by a doctor.-if bothersome dryness or peeling occurs, reduce application to oncea day or every other day.-throw away cloth (do not flush).

Storage And Handling

Other information   store at room temperature.

Inactive Ingredient

Inactive ingredientsWater, Propylene Glycol, Polysorbate 20,PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin,Kinginka Ekisu, Iodopropynol Butylcarbamate, Frangrance

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