NDC 74472-004 Some By Mi Aha Bha Pha 30 Days Miracle Acne Clear Body Cleanser

Salicylic Acid

NDC Product Information

Some By Mi Aha Bha Pha 30 Days Miracle Acne Clear Body Cleanser with NDC 74472-004 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 Acne Clear Body Cleanser is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Perennebell Co., Ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Acne Clear Body Cleanser 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/100g

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAURIC ACID (UNII: 1160N9NU9U)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • MYRISTIC ACID (UNII: 0I3V7S25AW)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • COCO-BETAINE (UNII: 03DH2IZ3FY)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • CAPRIC ACID (UNII: 4G9EDB6V73)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)
  • MANDELIC ACID (UNII: NH496X0UJX)
  • GLUCONIC ACID (UNII: R4R8J0Q44B)
  • LACTOBIONIC ACID (UNII: 65R938S4DV)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ASIATICOSIDE (UNII: PKO39VY215)
  • ASIATIC ACID (UNII: 9PA5A687X5)
  • MADECASSIC ACID (UNII: M7O1N24J82)
  • MADECASSOSIDE (UNII: CQ2F5O6YIY)
  • PROPOLIS WAX (UNII: 6Y8XYV2NOF)
  • HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)

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: 10-06-2020 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 Acne Clear Body Cleanser Product Label Images

Some By Mi Aha Bha Pha 30 Days Miracle Acne Clear Body Cleanser 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 0.5%

Otc - Purpose

Acne Treatment

Indications & Usage

For the treatment of Acne

Dosage & Administration

Take an appropriate amount on shower ball or shower towel to create a lather and gently massage over the body and wash it off with lukewarm water

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, Glycerin, Lauric Acid, Cocamidopropyl Betaine, Myristic Acid, Potassium Hydroxide, Coco-Betaine, Disodium Cocoamphodiacetate, Disodium Laureth Sulfosuccinate, Sodium Chloride, Melaleuca Alternifolia (Tea Tree) Extract, 1,2-Hexanediol, Centella Asiatica Extract, Eucalyptus Globulus Leaf Oil, Trideceth-10, Capric Acid, Palmitic Acid, Gardenia Florida Fruit Extract, Dextrin, Mandelic Acid, Gluconic Acid, Lactobionic Acid, Sodium hydroxide, Sodium Hyaluronate Crosspolymer, Artemisia Vulgaris Extract, Butylene Glycol, Asiaticoside, Asiatic acid, Madecassic Acid, Madecassoside, Propolis Extract, Houttuynia Cordata Extract, Disodium EDTA, Citric Acid, Sodium Benzoate, Hexylene glycol, Ethylhexylglycerin, Tocopherol, Limonene

* Please review the disclaimer below.