EARACHE RELIEF PM- apis mellifica, arnica montana, calcarea phosphorica, chamomilla,echinacea, hepar sulphuris calcareum, hoitzia, passiflora, valeriana officinalis liquid

EarAche Relief PM by

Drug Labeling and Warnings

EarAche Relief PM by is a Homeopathic medication manufactured, distributed, or labeled by TRP Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

PREGNANCY OR BREAST FEEDING

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

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

WARNINGS

• 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.

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.

SPL UNCLASSIFIED SECTION

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.

Questions or comments?

www.thereliefproducts.com, 1-888-969-6855

PRINCIPAL DISPLAY PANEL

FDA Disclaimer: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INGREDIENTS AND APPEARANCE

EARACHE RELIEF PM 
apis mellifica, arnica montana, calcarea phosphorica, chamomilla,echinacea, hepar sulphuris calcareum, hoitzia, passiflora, valeriana officinalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17312-173
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X]  in 1 mL
LOESELIA MEXICANA WHOLE (UNII: XA8YCV5M3E) (LOESELIA MEXICANA WHOLE - UNII:XA8YCV5M3E)	LOESELIA MEXICANA WHOLE	6 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z)	PASSIFLORA INCARNATA FLOWER	5 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	12 [hp_X]  in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR)	TRIBASIC CALCIUM PHOSPHATE	8 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	8 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17312-173-15	1 in 1 PACKAGE	09/19/2019
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/19/2019

Labeler - TRP Company (105185719)

Registrant - TRP Company (105185719)