NDC 71825-104 Cremo Anti-dandruff Fresh Blend

Pyrithione Zinc

NDC Product Code 71825-104

NDC Product Information

Cremo Anti-dandruff Fresh Blend with NDC 71825-104 is a a human over the counter drug product labeled by Cremo Company. The generic name of Cremo Anti-dandruff Fresh Blend is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Cremo Company

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 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.


Cremo Anti-dandruff Fresh Blend 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.

  • PYRITHIONE ZINC 1 g/100mL

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.

  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • WATER (UNII: 059QF0KO0R)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)

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: Cremo Company
Labeler Code: 71825
FDA Application Number: part358H 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: 01-11-2019 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.

Cremo Anti-dandruff Fresh Blend Product Label Images

Cremo Anti-dandruff Fresh Blend 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 ingredients PurposePyrithione Zinc 1% Anti-Dandruff

Otc - Purpose

Use Help prevent reccurence of flaking and itching associated with dandruff

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Posion Control Center immediately.

Indications & Usage

  • Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Warnings

  • WarningsFOR EXTERNAL USE ONLYWhen using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Dosage & Administration

  • DirectionsFor best results, use at least twice a week, or as directed by a doctorWet hair, massage onto scalp and rinserepeat if desired

Inactive Ingredient

Inactive ingredientsWater(aqua, Eau), Sodium Laureth Sulfate, Disodium Cocoamphodiacetate, Acrylates Copolymer, Glycerin, Cocamidopropyl Betaine, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, glycereth-2 Cocoate, Fragrance, Citric Acid.

* Please review the disclaimer below.

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