NDC 72288-822 Belei Oilfree Facial Cleansing Wipes

Salicylic Acid

NDC Product Code 72288-822

NDC Code: 72288-822

Proprietary Name: Belei Oilfree Facial Cleansing Wipes Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Salicylic Acid Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 72288 - Amazon.com Services, Inc
    • 72288-822 - Belei Oilfree Facial Cleansing Wipes

NDC 72288-822-25

Package Description: 2 PACKAGE in 1 CELLO PACK > 165 mL in 1 PACKAGE

NDC Product Information

Belei Oilfree Facial Cleansing Wipes with NDC 72288-822 is a a human over the counter drug product labeled by Amazon.com Services, Inc. The generic name of Belei Oilfree Facial Cleansing Wipes is salicylic acid. The product's dosage form is solution and is administered via topical form.

Labeler Name: Amazon.com Services, Inc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Belei Oilfree Facial Cleansing Wipes Active Ingredient(s)

Additional informationCallout TooltipWhat 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 2 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Amazon.com Services, Inc
Labeler Code: 72288
FDA Application Number: part333D Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Belei Oilfree Facial Cleansing Wipes Product Label Images

Belei Oilfree Facial Cleansing 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 ingredientsSalicylic Acid 2%

Otc - Purpose

PurposeAcne treatment

Indications & Usage

UsesTreats acne.Dries up acne pimple.

Warnings

WarningsFor external use only.

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.

Otc - When Using

When using this productSkin irritation and dryness are 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 the eyes.If product gets into eyes, rinse thoroughly with water.

Dosage & Administration

DirectionsOpen resealable label to access wipe; reseal label tightly to retain moisture.Thoroughly wipe face with cleansing cloth to deep clean and refresh skin.After use, dispose of wipe in a trash receptacle.Do not flush.Clean the skin thoroughly before applying this product.

References

Other informationLot Number and Expiration Date can be found on pack.

Inactive Ingredient

Inactive ingredientsAlcohol Denat.,Butylene Glycol, Citrus Grandis (Grapefruit) Fruit Extract, Disodium EDTA, Fragrance, Glycerin, Iodopropynyl Butylcarbamate, PED-32, Phenoxyethanol, PPG-5-Ceteth-20, Sodium Citrate, Sodium Hydroxide, SodiumXylenesulfonate, Water

* Please review the disclaimer below.

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