NDC 74472-003 Some By Mi Aha Bha Pha 30 Days Miracle Toner

Salicylic Acid

NDC Product Information

Some By Mi Aha Bha Pha 30 Days Miracle Toner with NDC 74472-003 is a a human over the counter drug product labeled by Perennebell Co., Ltd.. The generic name of Some By Mi Aha Bha Pha 30 Days Miracle Toner is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Perennebell Co., Ltd.

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.

Some By Mi Aha Bha Pha 30 Days Miracle Toner 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 .01 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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)
  • PAPAYA (UNII: KU94FIY6JB)
  • LENTIL (UNII: 6O38V6B52O)
  • HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
  • NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ADENOSINE (UNII: K72T3FS567)
  • HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
  • XYLITOL (UNII: VCQ006KQ1E)
  • LACTOBIONIC ACID (UNII: 65R938S4DV)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • 4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
  • PEPPERMINT OIL (UNII: AV092KU4JH)

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: Perennebell Co., Ltd.
Labeler Code: 74472
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: 10-05-2020 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: 12-31-2021 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.

Some By Mi Aha Bha Pha 30 Days Miracle Toner Product Label Images

Some By Mi Aha Bha Pha 30 Days Miracle Toner 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

Salicylic Acid 0.01%

Otc - Purpose

Acne Treatment

Indications & Usage

For the treatment of Acne

Dosage & Administration

Take an appropriate amount and spread evenly onto the skin.

Warnings

For external use only


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.


People with allergy to aspirin will react poorly to the Salicylic Acid.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Inactive Ingredient

Water, Butylene Glycol, Dipropylene Glycol, Glycerin, Niacinamide, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Polyglyceryl-4 Caprate, Carica Papaya (Papaya) Fruit Extract, Lens Esculenta (Lentil) Seed Extract, Hamamelis Virginiana (Witch Hazel) Extract, Nelumbo Nucifera Flower Extract, Swiftlet Nest Extract, Sodium Hyaluronate, Fructan, Allantoin, Adenosine, Hydroxyethyl Urea, Xylitol, Lactobionic Acid, Citric Acid, Sodium Citrate, 1,2-Hexanediol, Benzyl Glycol, Ethylhexylglycerin, Raspberry Ketone, Mentha Piperita (Peppermint) Oil

* Please review the disclaimer below.