NDC 52261-3800 Healthy Skin Cleanser

Salicylic Acid Cleanser

NDC Product Code 52261-3800

NDC Code: 52261-3800

Proprietary Name: Healthy Skin Cleanser 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 Cleanser 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
  • 52261 - Cosco International, Inc.
    • 52261-3800 - Healthy Skin Cleanser

NDC 52261-3800-1

Package Description: .069195 kg in 1 BOTTLE, PLASTIC

NDC Product Information

Healthy Skin Cleanser with NDC 52261-3800 is a a human over the counter drug product labeled by Cosco International, Inc.. The generic name of Healthy Skin Cleanser is salicylic acid cleanser. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Cosco International, Inc.

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 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.


Healthy Skin Cleanser 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 .02 kg/kg

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.

  • XANTHAN GUM (UNII: TTV12P4NEE)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)
  • PUMICE (UNII: NT5NN5KL16)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • WATERMELON (UNII: 231473QB6R)
  • APPLE (UNII: B423VGH5S9)
  • LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • KIWI FRUIT (UNII: 71ES77LGJC)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SORBIC ACID (UNII: X045WJ989B)

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

Healthy Skin Cleanser Product Label Images

Healthy Skin 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

Drug Facts

Active Ingredient                       PurposeSalicylic Acid (2%)......................Acne Treatment

Otc - Purpose

  • UseFor the treatment of acne

Warnings

WarningsFor externatl use only

Otc - Do Not Use

  • Do not useIf you are sensitive to Salicylic Acid or have very sensitive skin.This product may cause irritation.

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before useIf you are using other topical acne drugs at the same time or right after use of this product.  This may increase dryness, redness, or ittitation 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.

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 a dime-sized amount to damp skin and gently massage, avoiding the eye area.  Rinse well.  If peeling occurs, reduce application use.  May also be used on chest or back.

Inactive Ingredient

Inactive Ingredients  Actinidia Chinensis (Kiwi) Fruit Extract, Cannabidiol, Caprylyl Glycol, Citrullus Lanatis (Watermelon) Fruit Extract, Cocamide MEA, Cocamide MIPA, Cocamidopropyl Betaine, Disodium Cocoyl Glutamate, Ethylhexylglycerin, Glycerin, Lens Esculenta (Lentil) Fruit Extract, Medium-Chain Triglycerides, Phenoxyethanol, Pumice, Pyrus Malus (Apple) Fruit Extract, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Sodium Hydroxide, Sodium Lactate, Sodium Pyrrolidone Carboxylate, Sorbic Acid, Sorbitol, Water, Xanthan Gum

Otc - Questions

Questions?  hello@healthyskincbd.com

* Please review the disclaimer below.

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