NDC 17312-175 Ring Relief Pm Nighttime Formula

Arnica Montana, Calcium Sulfide, Hypericum Perforatum, Lycopodium Clavatum Spore, Thiosinaminum, Mercurius Solubilis, Salicylic Acid, Silicon Dioxide, Allylthiourea

NDC Product Code 17312-175

NDC Code: 17312-175

Proprietary Name: Ring Relief Pm Nighttime Formula 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: Arnica Montana, Calcium Sulfide, Hypericum Perforatum, Lycopodium Clavatum Spore, Thiosinaminum, Mercurius Solubilis, Salicylic Acid, Silicon Dioxide, Allylthiourea 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

  • 17312 - Trp Company

NDC 17312-175-15

Package Description: 1 BOTTLE, DROPPER in 1 PACKAGE > 10 mL in 1 BOTTLE, DROPPER

NDC Product Information

Ring Relief Pm Nighttime Formula with NDC 17312-175 is a a human over the counter drug product labeled by Trp Company. The generic name of Ring Relief Pm Nighttime Formula is arnica montana, calcium sulfide, hypericum perforatum, lycopodium clavatum spore, thiosinaminum, mercurius solubilis, salicylic acid, silicon dioxide, allylthiourea. The product's dosage form is liquid and is administered via auricular (otic) form.

Labeler Name: Trp Company

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.

Ring Relief Pm Nighttime Formula 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.

  • ARNICA MONTANA 6 [hp_X]/mL
  • CALCIUM SULFIDE 13 [hp_X]/mL
  • HYPERICUM PERFORATUM 6 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL
  • MATRICARIA CHAMOMILLA 12 [hp_X]/mL
  • SALICYLIC ACID 6 [hp_X]/mL
  • SILICON DIOXIDE 13 [hp_X]/mL
  • VALERIAN 6 [hp_X]/mL
  • PASSIFLORA INCARNATA FLOWER 5 [hp_X]/mL
  • ALLYLTHIOUREA 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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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.

  • Auricular (otic) - Administration to or by way of the ear.

Product Labeler Information

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

Labeler Name: Trp Company
Labeler Code: 17312
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: 09-19-2019 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.

Ring Relief Pm Nighttime Formula Product Label Images

Ring Relief Pm Nighttime Formula 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

Otc - Active Ingredient

Arnica montana HPUS 6X, 30X................Buzzing, chirping

Chamomilla HPUS 12X, 18X....................Pain, disturbed sleep

Hepar sulphuris calcareum HPUS 13X....Noise sensitivity

Hypericum perforatum HPUS 6X, 30X.....Nerve sensitivity

Lycopodium clavatum HPUS 12X............Pounding, ear wax buildup

Passiflora HPUS 5X.................................Relaxing, calming sleep aid

Salicylicum acidum HPUS 6X..................Ringing, buzzing

Silicea HPUS 13X....................................Roaring

Thiosinaminum HPUS 6X........................Ringing (Tinnitus)

Valeriana officinalis HPUS 6X..................Sleeplessness
"HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

Otc - Purpose

Arnica montana HPUS- Buzzing, chirping

Chamomilla HPUS - Pain, disturbed sleep

Hepar sulphuris calcareum HPUS - Noise sensitivity

Hypericum perforatum HPUS - Nerve sensitivity

Lycopodium clavatum HPUS - Pounding, ear wax buildup

Passiflora HPUS - Relaxing, calming sleep aid

Salicylicum acidum HPUS - Ringing, buzzing

Silicea HPUS - Roaring

Thiosinaminum HPUS - Ringing (Tinnitus)

Valeriana officinalis HPUS - Sleeplessness

Indications & Usage

Uses:*
According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Ringing, buzzing, roaring • Nerve and noise sensitivity • Pounding • Discomfort • Wax buildup • Sleeplessness; after serious causes have been ruled out by a physician.

*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

  • Warnings:A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. For External Use Only. This product is intended to complement, not replace, standard medical treatment.Initial worsening of symptoms may occur.

  • In case of accidental ingestion, get medical help or contact a Poison Control Center right away.Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Otc - Pregnancy Or Breast Feeding

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

Otc - Do Not Use

  • Do not use:If solution changes color or becomes cloudy.If you have ear drainage, discharge, irritation, a rash in the ear or dizziness.If you have ear tubes, after surgery or with damaged ear drums.

Keep Out Of Reach Of Children

• Keep out of reach of children.

Dosage & Administration

Directions:
• Suitable for adults and children ages 2 and over. Children under the age of 2: Consult a physician before use. • For use in ear only. • Use 3 to 5 drops before bedtime. • Warm contents to body temperature by holding bottle in your hands. • Tilt your head to the side and let solution drip into the ear. • Never put the tip into the ear canal. • Keep drops in your ear by tilting your head for 20 to 40 seconds. • Homeopathic remedies may not be effective for everyone. Individual results may vary. May take up to 60 days to see results.

Other

Other information:• Store at room temperature 15° to 30° C (59° to 86°F). • Keep bottle tightly closed. • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects or contraindications. • Ring Relief® PM Ear Drops are homeopathic dilutions, for details see www.thereliefproducts.com.

Inactive Ingredient

Inactive Ingredients:
Benzalkonium Chloride, Glycerin, Purified Water.

* Please review the disclaimer below.