NDC 17312-173 Earache Relief Pm

Apis Mellifica, Arnica Montana, Calcarea Phosphorica, Chamomilla,echinacea, Hepar Sulphuris Calcareum, Hoitzia, Passiflora, Valeriana Officinalis

NDC Product Code 17312-173

NDC Code: 17312-173

Proprietary Name: Earache Relief Pm 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: Apis Mellifica, Arnica Montana, Calcarea Phosphorica, Chamomilla,echinacea, Hepar Sulphuris Calcareum, Hoitzia, Passiflora, Valeriana Officinalis 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 17312-173-15

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

NDC Product Information

Earache Relief Pm with NDC 17312-173 is a a human over the counter drug product labeled by Trp Company. The generic name of Earache Relief Pm is apis mellifica, arnica montana, calcarea phosphorica, chamomilla,echinacea, hepar sulphuris calcareum, hoitzia, passiflora, valeriana officinalis. 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.

Earache Relief Pm 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.

  • VALERIAN 6 [hp_X]/mL
  • ARNICA MONTANA 6 [hp_X]/mL
  • ECHINACEA ANGUSTIFOLIA 3 [hp_X]/mL
  • APIS MELLIFERA 6 [hp_X]/mL
  • LOESELIA MEXICANA WHOLE 6 [hp_X]/mL
  • PASSIFLORA INCARNATA FLOWER 5 [hp_X]/mL
  • MATRICARIA CHAMOMILLA 12 [hp_X]/mL
  • TRIBASIC CALCIUM PHOSPHATE 8 [hp_X]/mL
  • CALCIUM SULFIDE 8 [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.

Earache Relief Pm 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

Apis mellifica HPUS 6x, 12x, 18x...........................Discomfort, redness of external ear

Arnica montana HPUS 6x, 12x, 18x.......................Bruised aching pain

Calcarea phosphorica HPUS 8x, 12x, 18x.............Itching, irritability

Chamomilla HPUS 12x,18x....................................Pain disturbs sleep, restlessness

Echinacea HPUS 3x...............................................Immune support

Hepar sulphuris calcareum HPUS 8x, 12x, 18x......Sensitive to touch, water, wind, cold

Hoitzia HPUS 6x, 12x, 18x......................................Fever, fullness

Passiflora HPUS 5x ................................................Sleep disorders, exhaustion

Valeriana officinalis HPUS 6x..................................Relaxing, calming sleep aid
"HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

Otc - Purpose

Apis mellifica HPUS - Discomfort, redness of external ear

Arnica montana HPUS - Bruised aching pain

Calcarea phosphorica HPUS - Itching, irritability

Chamomilla HPUS - Pain disturbs sleep, restlessness

Echinacea HPUS - Immune support

Hepar sulphuris calcareum - Sensitive to touch, water, wind, cold

Hoitzia HPUS - Fever, fullness

Passiflora HPUS - Sleep disorders, exhaustion

Valeriana officinalis HPUS - Relaxing, calming sleep aid

Indications & Usage

Uses:*
• According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Discomfort • Itching, coldness, irritability • Sensitivity to water, wind and touch • Fullness, congestion • 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.

*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.

Other

Other information:• Non-prescription drug products cannot treat infections. • Store at room temperature 15o to 30o C (59o to 86o 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. • EarAche 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.