Swimmers Ear Complete Relief

Manufacturer
TRP Company
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:35:55

Label at a glance#

ProductSwimmers Ear Complete Relief
Active ingredientPOTASSIUM CHLORIDE, CALCIUM SULFIDE, TRIBASIC CALCIUM PHOSPHATE, SILICON DIOXIDE, VALERIAN, LOESELIA MEXICANA TOP, MERCURIUS SOLUBILIS
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

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 SECTION

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 SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - DO NOT USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Inactive Ingredients:
Glycerin, Isopropyl alcohol 94%

Stop Use

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

CartonCarton

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130858961001761GTIN-13: 0858961001761
EAN-13: 0858961001761
GTIN-12: 858961001761
UPC-A: 858961001761
GTIN storage (14 digits): 00858961001761
TRP_SECR_DROP_CTN-11-15-19_r10-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17312-176-15Swimmers Ear Complete Relief1 in 1 PACKAGELIQUID13
17312-176-15Swimmers Ear Complete Relief10 mL in 1 BOTTLE, DROPPERLIQUID103

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17312-17617312-176-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Swimmers Ear Complete ReliefCALCIUM SULFIDE, LOESELIA MEXICANA TOP, MERCURIUS SOLUBILIS, POTASSIUM CHLORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, VALERIANTRP Companya3425da3-ace9-05c2-e053-2995a90ab09f2025-12-15WarningsExact identifier
ndc (package): 17312-176-15
ndc (product): 17312-176
ndc11 (package): 17312017615
spl id: 460664c1-3c32-ed20-e063-6294a90a5132
spl set id: a3425da3-ace9-05c2-e053-2995a90ab09f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.