NDC 77982-121 Flavobac Health Guard Complete

Mouth Spray Against Sore Throat Pain Irritation

NDC Product Code 77982-121

NDC CODE: 77982-121

Proprietary Name: Flavobac Health Guard Complete 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: Mouth Spray Against Sore Throat Pain Irritation 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

  • 77982 - Laboratoires Msp Inc

NDC 77982-121-11

Package Description: 1 BOTTLE in 1 BOX > 59 mL in 1 BOTTLE

NDC Product Information

Flavobac Health Guard Complete with NDC 77982-121 is a a human over the counter drug product labeled by Laboratoires Msp Inc. The generic name of Flavobac Health Guard Complete is mouth spray against sore throat pain irritation. The product's dosage form is spray and is administered via oral form.

Labeler Name: Laboratoires Msp Inc

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.

Flavobac Health Guard Complete 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.

  • MENTHOL .02 mg/100mL
  • GLYCERIN 10 mg/100mL

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.

  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • XYLITOL (UNII: VCQ006KQ1E)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • STEVIA LEAF (UNII: 6TC6NN0876)
  • ALCOHOL (UNII: 3K9958V90M)
  • ORANGE (UNII: 5EVU04N5QU)
  • CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
  • WATER (UNII: 059QF0KO0R)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)

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: Laboratoires Msp Inc
Labeler Code: 77982
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-14-2021 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.

Flavobac Health Guard Complete Product Label Images

Flavobac Health Guard Complete 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 Ingredient(S)

Menthol 0.02%................Anesthetic/AnalgesicGlycerin 10%...........................Oral Demulcent

Purpose

Anesthetic/AnalgesicOral Demulcent

Use

Temporary relief of occasional minor irritation, pain, sore mouth, sore throat, minor discomfort and protection of irritated areas in sore mouth and sore throat

Warnings

Sore throat warningIf sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptlyStop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days

If pregnant or breast-feeding, ask a health professional before use
Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
Do not exceed the recommended dosage. When using this product, try to avoid swallowing spray

Otc - When Using

Try to avoid swallowing spray

Pregnancy

If pregnant or breast-feeding, ask a health professional before use

Other Safety Information

Do not exceed the recommended dosage.

Otc - Stop Use

Sore mouth symptoms do not improve in 7 days

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

Adults and children 2 years of age and older: apply 4 sprays to the affected area. Gargle, swish around, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctorchildren under 12 years of age: should be supervised in the use of this product children under 2 years of age: not recommended

Inactive Ingredients

Water, bioflavonoids, xylitol, polysorbate 20, disodium phosphate, ethanol, orange flavor, potassium sorbate, stevia, sodium hyaluronate, sucralose

* Please review the disclaimer below.