NDC 81647-080 Arocell Mogong Clear Pads

Salicylic Acid

NDC Product Code 81647-080

NDC 81647-080-01

Package Description: 70 SWAB in 1 CARTON

NDC Product Information

Arocell Mogong Clear Pads with NDC 81647-080 is a a human over the counter drug product labeled by Ficc Co., Ltd.. The generic name of Arocell Mogong Clear Pads is salicylic acid. The product's dosage form is swab and is administered via topical form.

Labeler Name: Ficc 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.

Arocell Mogong Clear Pads 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 .0046 g/1

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)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)
  • TROMETHAMINE (UNII: 023C2WHX2V)

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: Ficc Co., Ltd.
Labeler Code: 81647
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: 03-01-2021 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: 12-31-2022 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 - NO 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.

Arocell Mogong Clear Pads Product Label Images

Arocell Mogong Clear Pads 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

Salicylic Acid 0.46%

Inactive Ingredients

Water, Methylpropanediol, Tromethamine, Lactic Acid, Alcohol, 1,2-Hexanediol, Polyglyceryl-10 Laurate , Glycerin, Glycereth-26, Ethylhexylglycerin, Polyglyceryl-10 Myristate, Allantoin, Betaine, Trehalose, Betaine Salicylate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Butylene Glycol, Sodium Hyaluronate, Eucalyptus Globulus Leaf Oil, Capryloyl Salicylic Acid, Lavandula Angustifolia (Lavender) Oil, Gluconolactone, Carica Papaya (Papaya) Fruit Extract, Mentha Arvensis Extract, Mentha Piperita (Peppermint) Leaf Extract, Mentha Rotundifolia Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Centella Asiatica Extract, Anthemis Nobilis Flower Water, Glycyrrhiza Glabra (Licorice) Root Extract, Aloe Barbadensis Leaf Juice, Chamaecyparis Obtusa Water, Pueraria Lobata Root Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Ulmus Davidiana Root Extract, Pinus Palustris Leaf Extract, Hydrolyzed Hyaluronic Acid, Panthenol, Palmitoyl Pentapeptide-4, Disodium EDTA, Limonene

Purpose

Acne Treatment

Warnings

For external use onlyConsult a specialist if there are abnormal symptoms or side effects such as redness, swelling or itchiness due to direct sunlight during or after use.Avoid using on wounded areas.Keep out of reach of children

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

■ For the treatment of acne.

Directions

■ After cleansing, gently wipe the entire face with embossing side.■ Use the opposite side of the pad to soothe skin.

Other Information

■ Keep away from direct sunlight.

* Please review the disclaimer below.