NDC 52261-3801 Healthy Skin Moisturizer

Benzoyl Peroxide Moisturizer

NDC Product Code 52261-3801

NDC Code: 52261-3801

Proprietary Name: Healthy Skin Moisturizer What 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: Benzoyl Peroxide Moisturizer What 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
  • 52261 - Cosco International, Inc.
    • 52261-3801 - Healthy Skin Moisturizer

NDC 52261-3801-1

Package Description: .0357 kg in 1 TUBE

NDC Product Information

Healthy Skin Moisturizer with NDC 52261-3801 is a a human over the counter drug product labeled by Cosco International, Inc.. The generic name of Healthy Skin Moisturizer is benzoyl peroxide moisturizer. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Cosco International, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.


Healthy Skin Moisturizer 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.

  • BENZOYL PEROXIDE .0625 kg/kg

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.

  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • WATER (UNII: 059QF0KO0R)
  • WATERMELON (UNII: 231473QB6R)
  • APPLE (UNII: B423VGH5S9)
  • LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • KIWI FRUIT (UNII: 71ES77LGJC)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SORBIC ACID (UNII: X045WJ989B)

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: Cosco International, Inc.
Labeler Code: 52261
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: 01-25-2019 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’.

* Please review the disclaimer below.

Healthy Skin Moisturizer Product Label Images

Healthy Skin Moisturizer 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

Drug Facts

Active Ingredient               PurposeBenzoyl Peroxide 2.5%.........Acne Treatment

Otc - Purpose

  • UseFor the treatment of acne.

Warnings

WarningsFor external use only

Otc - Do Not Use

  • Do not useIf you are sensitive to Benzoyl Peroxide or have very sensitive skin.  This product may cause irritation.If you are pregnant or breast feeding.

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before useIf you are using other topical ance drugs at the same time or right after use of this product.  This may increase dryness, redness, or irritation of the skin.  If this occurs, only one medication should be used unless a doctor directs otherwise.

Indications & Usage

  • When using this productAvoid contact with eyes.  If contact occurs, flush thoroughly with water.  Keep away from lips and mouth.Avoid unneccesary sun exposure and use a sunscreen.Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Otc - Stop Use

  • Stop use and ask a doctorIf excessive irritation occurs.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsUse every morning and evening.  Apply to entire face, avoiding the eye area.  Do not rinse.  If peeling occurs, reduce application use.  May also be used on chest and back.

Inactive Ingredient

Inactive Ingredients  .Alpha.Tocopherol, DL-, Actinidia Chinensis (Kiwi) Fruit Extract, Aminomethylproanol, Cannabis Sativa Seed Oil, Caprylyl Glycol, Cetyl Alcohol, Citrullus Lanatis (Watermelon) Fruit Extract, Ethylhexylglycerin, Glycerin, Glyceryl Monostearate, Isopropyl Palmitate, Lens Esculenta (Lentil) Fruit Extract, Medium-Chain Triglycerides, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Pyrus Malus (Apple) Fruit Extract, Sodium Lactate, Sodium Pyrrolidone Carboxylate, Sorbic Acid, Stearic Acid, Water, Xanthan Gum

Otc - Questions

Questions?  Hello@healthyskincbd.com

* Please review the disclaimer below.

Previous Code
52261-3800
Next Code
52261-4700