Label: SWIMMERS EAR COMPLETE RELIEF- calcium sulfide, loeselia mexicana top, mercurius solubilis, potassium chloride, silicon dioxide, tribasic calcium phosphate, valerian liquid
- NDC Code(s): 17312-176-15
- Packager: TRP Company
- 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 January 10, 2023
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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.
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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
- PREGNANCY OR BREAST FEEDING
- DO NOT USE
- Keep out of reach of children
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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.
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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
- Questions or comments?
- Stop Use
- Ask doctor
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SWIMMERS EAR COMPLETE RELIEF
calcium sulfide, loeselia mexicana top, mercurius solubilis, potassium chloride, silicon dioxide, tribasic calcium phosphate, valerian liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17312-176 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 12 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 13 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE 12 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 13 [hp_X] in 1 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 6 [hp_X] in 1 mL LOESELIA MEXICANA TOP (UNII: BYW8H93R0X) (LOESELIA MEXICANA TOP - UNII:BYW8H93R0X) LOESELIA MEXICANA TOP 12 [hp_X] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17312-176-15 1 in 1 PACKAGE 04/11/2020 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 04/11/2020 Labeler - TRP Company (105185719) Registrant - TRP Company (105185719)