NDC 51048-202 Odorono Antiperspirant And Deodorant Roll-on Powder

Aluminum Chlorohydrate

NDC Product Code 51048-202

NDC 51048-202-25

Package Description: 74 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Odorono Antiperspirant And Deodorant Roll-on Powder with NDC 51048-202 is a a human over the counter drug product labeled by Omega & Delta Co. The generic name of Odorono Antiperspirant And Deodorant Roll-on Powder is aluminum chlorohydrate. The product's dosage form is liquid and is administered via topical form.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Odorono Antiperspirant And Deodorant Roll-on Powder 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)
  • PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
  • STEARETH-2 (UNII: V56DFE46J5)
  • STEARETH-21 (UNII: 53J3F32P58)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • TRICLOSAN (UNII: 4NM5039Y5X)

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: Omega & Delta Co
Labeler Code: 51048
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: 05-08-2006 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.

Odorono Antiperspirant And Deodorant Roll-on Powder Product Label Images

Odorono Antiperspirant And Deodorant Roll-on Powder 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

24 HORAS DE PROTECCIÓN    !Odorono, Sí Responde!USO: Reduce la humedad en las axilas. PRECAUCIONES: Solo para uso externo. No usar sobre piel irritada o lastimada. Detenga su uso si presenta irritación o alguna molestia. Mantengase fuera del alcance de los niños. Si se ingiere buscar ayuda médica. INSTRUCCIONES DE USO: Aplique unicamente en las axilas. INGREDIENTE ACTIVO: Clorohidrato de aluminio OTROS INGREDIENTES: Agua, PPG-15 estearil éter, Estearet-2, Estearet-21, Fragancia, EDTA disódico, BHT, Triclosán. IMPORTADO Y DISTRIBUIDO POR:El Salvador - Dizac S.A. de C.V., Registro No. 1EC94191208 Panamá - Medimex S.A., Registro No. 64611 Nicaragua - Contesa S.A., Registro No. México - Grupo Agroindustrial San Miguel, Candido Aviles #37 Col. Lomas de Memetla Distrito Federal, C.P. 05330 R.F.C. GAS960629976.

Drug Facts

Hecho en Puerto Rico por:Omega & Delta Co., Inc.P.O. Box 1831, Carolina, P.R. 00984

Active Ingredients

Aluminum Chlorohydrate 20%

Purpose

Antiperspirant

Indications & Usage

Use: Reduces underarm wetness

Warnings

Warnings: For external use only

Otc - Do Not Use

Do not use on broken skin

Otc - Stop Use

Stop use if rash or irritation occurs

Otc - Ask Doctor

Ask a doctor before use if you have kidney disease

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center.

Dosage & Administration

Directions:  Apply evenly to underarms only

Inactive Ingredient

Inactive Ingredients:  Water, PPG-15 Stearyl Ether, Steareth-2, Steareth-21, Fragrance, Disodium EDTA, BHT, Triclosan

* Please review the disclaimer below.