NDC 82332-102 Bdferm Biospray

Calcium Oxide

NDC Product Code 82332-102

NDC 82332-102-01

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC Product Information

Bdferm Biospray with NDC 82332-102 is a a human over the counter drug product labeled by Bdferm Co.,ltd. The generic name of Bdferm Biospray is calcium oxide. The product's dosage form is spray and is administered via oral form.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Bdferm Biospray 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)
  • SUCROSE (UNII: C151H8M554)
  • BACILLUS SUBTILIS (UNII: 8CF93KW41W)
  • LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)
  • SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
  • ASPERGILLUS FLAVUS VAR. ORYZAE (UNII: Q6Z8UK5R3G)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bdferm Co.,ltd
Labeler Code: 82332
Marketing Category: UNAPPROVED DRUG OTHER - 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: 10-18-2021 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: 12-31-2022 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.

Bdferm Biospray Product Label Images

Bdferm Biospray 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

Active Ingredients

Calcium Oxide 0.295%

Purposes

Reduces bacterial and viral growth in the mouth.

Uses

Spray it two to four times a day in the mouth and on hands.

Storage And Handling

Avoid direct sunlight and store it in a cool place.

Inactive Ingredients

Purified water, BD FERM LEVAN K, BE FERM SYNBIOTICS, green grape scent

Directions

Spray it two to four times a day in the mouth and on hands.

Warnings

For external use only : wash it as soon as it gets into your eyes.

Stop use and ask a doctor if irritation or rash occurs.

Do not use on damaged or irritated skin.

Keep out of reach of children.

When Using

When using this product avoid contact with the eyes.

Pakage Label 82332-102

82332-102

* Please review the disclaimer below.