SWIMMERS EAR COMPLETE RELIEF- calcium sulfide, loeselia mexicana top, mercurius solubilis, potassium chloride, silicon dioxide, tribasic calcium phosphate, valerian liquid

Swimmers Ear Complete Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

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.

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 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)