NDC 58503-065 Xtracare 2 In 1 Hair Cleanse And Condition Green Apple

Pyrithione Zinc

NDC Product Code 58503-065

NDC CODE: 58503-065

Proprietary Name: Xtracare 2 In 1 Hair Cleanse And Condition Green Apple 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: Pyrithione Zinc 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.

NDC Code Structure

  • 58503 - China Ningbo Shangge Cosmetic Technology Corp.
    • 58503-065 - Xtracare 2 In 1 Hair Cleanse And Condition

NDC 58503-065-01

Package Description: 400 g in 1 BOTTLE

NDC Product Information

Xtracare 2 In 1 Hair Cleanse And Condition Green Apple with NDC 58503-065 is a a human over the counter drug product labeled by China Ningbo Shangge Cosmetic Technology Corp.. The generic name of Xtracare 2 In 1 Hair Cleanse And Condition Green Apple is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

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.

Xtracare 2 In 1 Hair Cleanse And Condition Green Apple 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.

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)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: China Ningbo Shangge Cosmetic Technology Corp.
Labeler Code: 58503
FDA Application Number: part358H 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: 08-27-2014 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 - NO 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".

* Please review the disclaimer below.

Xtracare 2 In 1 Hair Cleanse And Condition Green Apple Product Label Images

Xtracare 2 In 1 Hair Cleanse And Condition Green Apple 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 Ingredient                                      PurposePyrithione Zinc 0.5% .......................... Anti-dandruff

Otc - Purpose

UsesHelps prevent recurrence of flaking and itching associated with dandruff.

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.

Indications & Usage

XtraCare Pyrithione Zinc2 in 1 DandruffShampoo + ConditionerGreen Applehelps to relieve itching, dryness, and flaking


WarningsFor external use onlyWhen using this productAvoid contact wiht eyes. If contact occurs, rinse eyes thoroughly with water.Stop use and ask a doctor ifCondition worsens or does not improve after regular use of this product as directed.

Dosage & Administration

DirectionsWet hair, massage onto scalp, rinse. Repeat if desired. For best results use at least twice a week or as directed by a doctor.

Inactive Ingredient

Inactive Ingredientswater, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, cocamide MEA, carbomer, glycerin, fragrance, citric acid, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone.

Other Safety Information

Other InformationStore at 20C to 25C (68F to 77F)Questions/Comments? 1-855-345-5575DISTRIBUTED BY:REJOICE INTERNATIONAL INC.NORTHVILLE, MI 48168, USAMADE IN CHINA

* Please review the disclaimer below.