FDA.reportPublic FDA data

Ear Relief Ear Drops

Manufacturer
We Care Distributor Inc. | PURINE PHARMA LLC
Effective date
2016-09-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:08:10

Label at a glance#

ProductEar Relief Ear Drops
Active ingredientCHAMOMILE, MERCURIUS SOLUBILIS, SULFUR
Label structure17 sections

Indications and uses

According to homeopathic principles the ingredients of this medication give you temporary relief from symptoms due to: drafts and the annoyance of water-clogged ears by helping clear water trapped in the ear.

Dosage and administration

Remove tamper proof seal Tilt head sideways Apply 3-4 drops into affected ear from one to several times daily for no more than 48 hours, or as directed by a physician Tip of the bottle should not enter ear canal Keep drops in ear by keeping head tilted or placing cotton in ear. Use before expiration date For ages 2 and over

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chamomilla 10X

Purpose

OTC - PURPOSE SECTION

sensitivity to drafts, soothing

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mercurius solubilis 15X      

Purpose

OTC - PURPOSE SECTION

fullness, sensitivity to cold

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulphur 12X      

Purpose

OTC - PURPOSE SECTION

itchiness, sensitivity to water

Uses:

INDICATIONS & USAGE SECTION

According to homeopathic principles the ingredients of this medication give you temporary relief from symptoms due to:

  • drafts and the annoyance of water-clogged ears by helping clear water trapped in the ear.

Warnings:

WARNINGS SECTION

  • Do not use in the eyes.
  • Do not take internally by mouth
  • Initial exacerbation may occur.
  • The preparation must not be used if there is any damage to the ear drum, do not use with ear tubes.
  • This product does not treat ear aches caused by an ear infection. Ear infections must be treated by a physician and proper medication that must be prescribed by a physician.
  • If ear infections are not treated properly then may cause loss of hearing and deafness.
  • Use only if bottle seal in intact.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • ear drainage or discharge
  • pain, irritation, or rash in the ear
  • had ear surgery
  • dizzines

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • irritation (too much burning) or pain occurs
  • symptoms persist for more than 48 hours

If pregnant or breast feeding;

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or consult a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Remove tamper proof seal
  • Tilt head sideways
  • Apply 3-4 drops into affected ear from one to several times daily for no more than 48 hours, or as directed by a physician
  • Tip of the bottle should not enter ear canal
  • Keep drops in ear by keeping head tilted or placing cotton in ear.
  • Use before expiration date
  • For ages 2 and over

Other information:

SPL UNCLASSIFIED SECTION

  • Store in a cool and dry place, Protect from sunlight and moisture
  • Keep in a tightly closed container

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Glycerin, USP

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ear Relief Ear Drops
EAR DROPS
10 ml / 0.33 fl oz

Ear Relief EAR DROPS 10 ml / 0.33 fl ozEar Relief EAR DROPS 10 ml / 0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70005-034-012020-01-31C16284748780-19d75b9d1-1d34-f424-e053-dadaa90a57ceEar Relief Ear Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-034-01Ear Relief Ear Drops1 in 1 BOXSOLUTION14
70005-034-01Ear Relief Ear Drops10 mL in 1 BOTTLE, DROPPERSOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-034EAR RELIEF EAR DROPS (CHAMOMILLA, MERCURIUS SOLUBILIS, AND SULPHUR) SOLUTION [WE CARE DISTRIBUTOR INC.]4Legacy NDC, 2 package rows20160924_88868c00-cbdd-44b0-9e4d-b49efef54e09.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70005-03470005-034-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHAMOMILEFGL3685T2XACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
SULFUR70FD1KFU70ACTIB
GLYCERINPDC6A3C0OXIACT

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
e04513ed-8659-4749-9ca7-12c4459c331688868c00-cbdd-44b0-9e4d-b49efef54e092016-09-23WarningsExact identifier
spl id: e04513ed-8659-4749-9ca7-12c4459c3316
spl set id: 88868c00-cbdd-44b0-9e4d-b49efef54e09

Reported adverse events (FAERS/openFDA)#

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