NDC 40104-433 Modesa 2 In 1 Dandruff Green Apple

Pyrithione Zinc

NDC Product Code 40104-433

NDC Code: 40104-433

Proprietary Name: Modesa 2 In 1 Dandruff 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

  • 40104 - Ningbo Pulisi Daily Chemical Products Co., Ltd.
    • 40104-433 - Modesa 2 In 1 Dandruff Green Apple

NDC 40104-433-01

Package Description: 396.9 g in 1 PACKAGE

NDC Product Information

Modesa 2 In 1 Dandruff Green Apple with NDC 40104-433 is a a human over the counter drug product labeled by Ningbo Pulisi Daily Chemical Products Co., Ltd.. The generic name of Modesa 2 In 1 Dandruff Green Apple is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Ningbo Pulisi Daily Chemical Products Co., Ltd.

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.

Modesa 2 In 1 Dandruff 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.

  • PYRITHIONE ZINC 1 g/100g

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)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
  • ZINC SULFATE (UNII: 89DS0H96TB)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CITRIC ACID, 1-STEARYL ESTER (UNII: E945AJ51FA)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)

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: Ningbo Pulisi Daily Chemical Products Co., Ltd.
Labeler Code: 40104
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: 04-02-2019 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.

Modesa 2 In 1 Dandruff Green Apple Product Label Images

Modesa 2 In 1 Dandruff 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             1.00%                            Anti-dandruff

Otc - Purpose

Helps prevent to recurrence of flaking and itching associated with dandruff.

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away.Avoid contact with eyes, if contact occurs rinse eyes with plenty of water.

Indications & Usage

Shake well.for maximum dandruff control, use every time you shampoo.wet hair, squeeze small amount to palm, lather, rinse well for best results use at least twice a week or as directed by a doctor.

Warnings

For external use only.Stop use and ask a doctor if Condition worsens or does not improve after regular use as directed.

Dosage & Administration

Small amount to palm, or as directed by a doctor.

Inactive Ingredient

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

* Please review the disclaimer below.

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