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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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EarAche Relief ® PM Nighttime Formula

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.

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

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:

A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. For External Use Only.

Stop use and ask a doctor if: • You experience ear pain or worsening symptoms. • Symptoms last longer than 7 days.

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

Do not use:

Keep out of reach of children

Keep out of reach of children

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 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 Ingredients:
Benzalkonium Chloride, Glycerin, Purified Water.

Questions or comments?

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

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

Carton

Label

EARACHE RELIEF PM 
apis mellifica, arnica montana, calcarea phosphorica, chamomilla,echinacea, hepar sulphuris calcareum, hoitzia, passiflora, valeriana officinalis liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-173
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA12 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 1 mL
LOESELIA MEXICANA WHOLE (UNII: XA8YCV5M3E) (LOESELIA MEXICANA WHOLE - UNII:XA8YCV5M3E) LOESELIA MEXICANA WHOLE6 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER5 [hp_X]  in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE8 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE8 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17312-173-151 in 1 PACKAGE09/19/2019
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/19/2019
Labeler - TRP Company (105185719)
Registrant - TRP Company (105185719)

Revised: 9/2023
Document Id: 07f29bd8-c07a-d36b-e063-6294a90ab651
Set id: 92ee4f15-7315-7a46-e053-2995a90a7d0a
Version: 4
Effective Time: 20230918
 
TRP Company