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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated September 18, 2023

If you are a consumer or patient please visit this version.

  • 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.

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

  • 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.

    Carton

    Label

  • 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 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)