Label: SWIMMERS EAR COMPLETE RELIEF- calcium sulfide, loeselia mexicana top, mercurius solubilis, potassium chloride, silicon dioxide, tribasic calcium phosphate, valerian 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 April 11, 2020

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

  • ACTIVE INGREDIENT

    Calcarea phosphorica HPUS 12X, 18X...............Itching, irritability
    Hepar sulphuris calcareum HPUS 12X, 18X.......Sensitive to touch, water
    Hoitzia HPUS 12X, 18X.......................................Fullness in the ear, water, pain and discomfort
    Kali muriaticum HPUS 12X, 18X ........................Clogged ear
    Mercurius solubilis HPUS 12X, 18X....................Swimmer's ear irritation
    Valeriana officinalis HPUS 12X, 18X...................Relaxing, calming

    "HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Calcarea phosphorica HPUS - Itching, irritability
    Hepar sulphuris calcareum HPUS - Sensitive to touch, water
    Hoitzia HPUS - Fullness in the ear, water, pain and discomfort
    Kali muriaticum HPUS - Clogged ear
    Mercurius solubilis HPUS - Swimmer's ear irritation
    Valeriana officinalis HPUS - Relaxing, calming

  • INDICATIONS & USAGE

    Uses:*
    According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Sensitivity to touch in ear • Pain and discomfort • Water/Congestion in ear • Swimmer’s ear irritation; 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.

    Flammable: Keep away from fire or flame.

  • PREGNANCY OR BREAST FEEDING

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

  • DO NOT USE

    Do not use: in the eyes. If contact occurs, rinse eyes thoroughly with water

  • Keep out of reach of children

    • Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • 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. • Apply 4-5 drops in each affected ear. • 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 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. • Swimmer’s Ear Complete Relief TM Ear Drops are homeopathic dilutions, for details see www.thereliefproducts.com.

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Glycerin, Isopropyl alcohol 94%

  • Questions or comments?

  • Stop Use

    Stop use and ask a doctor if: •You experience ear pain, irritation (too much burning) or worsening symptoms. • Your symptoms last longer than 7 days

  • Ask doctor

    Ask a doctor before use if you have: • Ear Drainage or discharge • pain, irritation, or a rash in the ear • dizziness • had ear surgery

  • PRINCIPAL DISPLAY PANEL

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

    Carton

    Label

  • INGREDIENTS AND APPEARANCE
    SWIMMERS EAR COMPLETE RELIEF 
    calcium sulfide, loeselia mexicana top, mercurius solubilis, potassium chloride, silicon dioxide, tribasic calcium phosphate, valerian liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-176
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE12 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE13 [hp_X]  in 1 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE12 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE13 [hp_X]  in 1 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]  in 1 mL
    LOESELIA MEXICANA TOP (UNII: BYW8H93R0X) (LOESELIA MEXICANA TOP - UNII:BYW8H93R0X) LOESELIA MEXICANA TOP12 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17312-176-151 in 1 PACKAGE04/11/2020
    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 homeopathic04/11/2020
    Labeler - TRP Company (105185719)
    Registrant - TRP Company (105185719)