NDC 30142-788 Clean Apple
Pyrithione Zinc Shampoo Topical

Product Information

Clean Apple is a human over the counter drug product labeled by Kroger. The generic name of Clean Apple is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Product Code30142-788
Proprietary Name 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.
Clean Apple
Non-Proprietary Name 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.
Pyrithione Zinc
Product Type 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.
Human Otc Drug
Dosage FormShampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.
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.
Kroger
Labeler Code30142
FDA Application Number 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.
part358H
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-06-2013
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Clean Apple?


Product Packages

NDC 30142-788-15

Package Description: 420 mL in 1 BOTTLE, PLASTIC

Product Details

What are Clean Apple Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Clean Apple Active Ingredients UNII Codes

Clean Apple Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Clean Apple Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Pyrithione zinc 1%


Purpose



Anti-dandruff


Use



helps prevent recurrence of flaking and itching associated with dandruff


Warnings



For external use only


When Using This Product



  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor If



  • condition worsens or does not improve after regular use as directed

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • shake well
  • for manimum dandruff control, use every time you shampoo
  • wet hair, massage onto scalp, rinse, repeat if desired
  • for best results use at least twice a week or as directed by a doctor

Inactive Ingredients



water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5


Questions Or Comments



1-800-632-6900


Other



Multiple benefit formula to help:

  • fight dry scalp
  • Calm itch
  • releive irritation
  • Soothe and reduce redness
  • Reduce oiliness
  • Prevent flakes
  • Leave hair healthy looking
  • Head & Shoulders is a registered trademark of the Procter & Gmble Co. Cincinniti, OH 45202.  The Procter  & Gamble  Co is not affleted with the The Kroger Co or this product

    DISTRIBUTED BY THE KROGER CO

    CINCINNATI, OH 452022

    QUESTION OR COMMENTS

    WWW.KROGER.COM

    PLEASE RECYCLE


Principal Display Panel



Compare to

Head & Shoulders Green Apple

2 in 1 Dandruff Shampoo

SEE BACK PANEL

Kroger

PYRITHIONE ZINC

PLUS CONDITIONER

HELPS PREVENT

REOCCURRING

FLAKES

GREEN APPLE

everyday cleansing

with a clean, apple scent

14.2 FL OZ (420 mL)


* Please review the disclaimer below.