NDC 11084-816 Bactoshield Chg

Chlorhexidine Gluconate

NDC Product Code 11084-816

NDC CODE: 11084-816

Proprietary Name: Bactoshield Chg 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: Chlorhexidine Gluconate 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.

NDC Code Structure

  • 11084 - Deb Usa, Inc.

NDC 11084-816-10

Package Description: 30 APPLICATOR in 1 BOX > 25 mL in 1 APPLICATOR (11084-816-09)

NDC Product Information

Bactoshield Chg with NDC 11084-816 is a a human over the counter drug product labeled by Deb Usa, Inc.. The generic name of Bactoshield Chg is chlorhexidine gluconate. The product's dosage form is sponge and is administered via topical form.

Labeler Name: Deb Usa, Inc.

Dosage Form: Sponge - A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.

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.

Bactoshield Chg 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.

  • CHLORHEXIDINE GLUCONATE 40 mg/mL

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.

  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • LANOLIN (UNII: 7EV65EAW6H)
  • WATER (UNII: 059QF0KO0R)

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: Deb Usa, Inc.
Labeler Code: 11084
FDA Application Number: NDA019822 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: NDA - A product marketed under an approved New Drug Application. 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: 08-31-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 08-31-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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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Bactoshield Chg 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

Active Ingredient

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Use

  • Surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

For external use only

Allergy Alert

  • This product may cause a severe allergic realction. Symptoms may include:wheezing/difficulty breathinghivesshockrashfacial swellingIf an allergic reaction occurs, stop use and seek medical help right away.

Do Not Use

  • If you are allergic to chlorhexidine gluconate or any other ingredients in this product.

When Using This Product

  • Keep out of eyes, ears and mouth. May cause serious and permanent eye injury if permitted to enter or allowed to remain.if contact occurs, rinse with cold water right awaydo not use routinely if you have wounds which involve more than the superficial layers of the skin

Otc - Stop Use

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

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.

Directions

  • Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.open packagewet hands and forearms to the elbows with warm waterclean under nails with nail pick provided. Nails should be maintained with a 1 millimeter free edgewet sponge and squeeze to work up latherscrub thoroughly for 3 minutes, paying particular attention to the nails, cuticles and interdigital spaces. Use the brush side to clean the nails, cuticles and interdigital spaces between the fingers and the sponge side to scrub the hands and forearmsrinse thoroughly with warm waterscrub for an additional 3 minutes using the sponge sidediscard brush-spongerinse hands and forearms thoroughly and dry with a sterile towel

Other Information

  • Store between 20-25°C (68-77°F)avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Cocamide DEA, fragrance POFL 147, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions?

1-866-783-0422 (Monday to Friday 8 AM - 5 PM EST)

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