NDC 54973-3405 Canker Sore Relief Rinse

Goldenseal, Myrrh, Echinacea Angustifolia And Sodium Chloride

NDC Product Code 54973-3405

NDC CODE: 54973-3405

Proprietary Name: Canker Sore Relief Rinse 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: Goldenseal, Myrrh, Echinacea Angustifolia And Sodium Chloride 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 product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

NDC Code Structure

NDC 54973-3405-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 236 mL in 1 BOTTLE, PLASTIC

NDC 54973-3405-2

Package Description: 5 mL in 1 PACKET

NDC Product Information

Canker Sore Relief Rinse with NDC 54973-3405 is a a human over the counter drug product labeled by Hyland's. The generic name of Canker Sore Relief Rinse is goldenseal, myrrh, echinacea angustifolia and sodium chloride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Hyland's

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.

Canker Sore Relief Rinse 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.

  • ECHINACEA ANGUSTIFOLIA 6 [hp_X]/mL
  • SODIUM CHLORIDE 30 [hp_X]/mL
  • MYRRH 4 [hp_X]/mL
  • GOLDENSEAL 6 [hp_X]/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.

  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • WATER (UNII: 059QF0KO0R)
  • MANDARIN OIL (UNII: NJO720F72R)
  • BITTER ORANGE OIL (UNII: 9TLV70SV6I)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)

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.
  • 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: Hyland's
Labeler Code: 54973
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 11-01-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Canker Sore Relief Rinse Product Label Images

Canker Sore Relief Rinse 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

Echinacea 6X HPUSHydrastis 6X HPUSMyrrha 4X HPUSNatrum Muriaticum 30X HPUS"HPUS" indicates that the active ingredients are in theofficial Homeopathic Pharmacopoeia of the United States.

Purpose

Canker soresdiscomfort of gums or tongue due to canker sorescanker soresdiscomfort of gums or tongue due to canker sores

Uses

  • Temporarily relieves the symptoms of canker sores, including discomfort of gums or tongue

Warnings

As with any drug, ask a doctor before use if pregnantor breast-feeding.

Other

Do not use more than directed.
DO NOT SWALLOW.

  • Consult a dentist or physician if:symptoms persist for more than 7 days or worsen.swelling, rash or fever develops.irritation, pain or redness persists or worsens.

In case of emergency or if you accidentally swallow more than used for rinsing, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

* CLAIMS BASED ON TRADITIONAL HOMEOPATHICPRACTICE, NOT ACCEPTED MEDICAL EVIDENCE.NOT FDA EVALUATED.

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children.

Directions

  • Shake well before usingMeasure only with the dosing cup provided.Do not use dosing cup with other products.On dosing cup, mL = milliliter.Adults and children12 years and overRinse 10 mL around in mouth over affected area for at least one minute, then spit out. Use up to four timesdaily until relieved. Do not swallow.Children 6 years to under 12 yearsUse under supervision. Rinse 5 mL around in mouth over affected area for at least one minute, then spit out. Use up to four times daily until relieved. Do not swallow.Children under6 yearsConsult a dentist or physician.

Other Information

  • Do not use if imprinted "SEALED FOR YOURPROTECTION" tamper-evident bottle cap band is broken or missing.The inner packaged bottle is child-resistant.Store at room temperature.Do not refrigerate.

Inactive Ingredients

Citric Acid, Citrus Extract, Glycerine, Hydroxyethyl Cellulose, Purified Water, Sodium Citrate.

* Please review the disclaimer below.