NDC 71825-113 Cremo Anti-perspirant Deodorant Silver Water And Birch

Aluminum Zirconium Tetrachlorohydrex Glycine

NDC Product Code 71825-113

NDC CODE: 71825-113

Proprietary Name: Cremo Anti-perspirant Deodorant Silver Water And Birch 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: Aluminum Zirconium Tetrachlorohydrex Glycine 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

  • 71825 - Cremo Company

NDC 71825-113-75

Package Description: 75 g in 1 CONTAINER

NDC Product Information

Cremo Anti-perspirant Deodorant Silver Water And Birch with NDC 71825-113 is a a human over the counter drug product labeled by Cremo Company. The generic name of Cremo Anti-perspirant Deodorant Silver Water And Birch is aluminum zirconium tetrachlorohydrex glycine. The product's dosage form is stick and is administered via topical form.

Labeler Name: Cremo Company

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Cremo Anti-perspirant Deodorant Silver Water And Birch 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.

  • ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 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.

  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • PEG-8 DILAURATE (UNII: FC11NGP7E6)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)

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.
  • 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: Cremo Company
Labeler Code: 71825
FDA Application Number: part350 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: 01-01-2020 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 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’.

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Cremo Anti-perspirant Deodorant Silver Water And Birch Product Label Images

Cremo Anti-perspirant Deodorant Silver Water And Birch 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

Other

Drug Facts

Cremocompany.comDist. by Cremo Company, LLCLaguna Beach, CA 92651©2019 Cremo Co.Not tested on animals.

Otc - Active Ingredient

Active ingredientAluminum Zirconium Tetrahydrochlorhydrex Glycine 19%

Otc - Purpose

PurposeAntiperspirant

Indications & Usage

UseReduces underarm wetness

Warnings

WarningsFor external use only

Otc - Do Not Use

Do not use on broken skin

Otc - Ask Doctor

Ask a doctor before use if you have kidney disease

Otc - Stop Use

Stop use if rash or irritation occurs

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

Dosage & Administration

  • DirectionsApply to underarms onlyHold product to skin to soften on contact with body heat, using only a small amount of product

Inactive Ingredient

Inactive ingredients Cyclopentasiloxane, Stearyl Alcohol, Hydrogenated Castor Oil, Fragrance (Parfum), Silica, PEG-8 Dilaurate, Aluminum Starch Octenylsuccinate

Otc - Questions

Questions?Call toll-free
800-853-1762

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