EAR CARE EARACHE DROPS

Manufacturer
Rite Aid Corporation
Effective date
2018-03-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:09:17

Label at a glance#

ProductEAR CARE EARACHE DROPS
Active ingredientATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, LYCOPODIUM CLAVATUM SPORE, ANEMONE PULSATILLA, SULFUR
Label structure9 sections

Indications and uses

• For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of fever, pain, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common pain and itching of “swimmers ear”. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Dosage and administration

Suitable for adults and children over the age of 2. • For use in the ears only • Remove any hearing aids • Use 3-5 drops twice per day or as needed. Warm contents to body temperature by holding bottle in your hands. Tilt ear upward for at least 2 minutes after application or gently place cotton in ear to keep drops in. Tilt your head to the side and let solution drip into the ear. Never put the tip in the ear cana...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
"HPUS" indicates the components of this product are officially monographed in the Homeopathic Pharmacopœia of the United States.
Belladonna 30C HPUSFever
Calcarea Carbonica 30C HPUSThrobbing ear pain
Chamomilla 30C HPUSSleeplessness and irritability
Lycopodium 30C HPUSEar pain
Pulsatilla 30C HPUSEar itching, pain worse at night
Sulphur 30C HPUSEar pain with burning

Uses*

INDICATIONS & USAGE SECTION

• For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of fever, pain, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common pain and itching of “swimmers ear”. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

WARNINGS SECTION

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN. Keep away from eyes. This product is intended to complement, not replace, standard medical treatment. Initial worsening of symptoms may occur. A physician should always be consulted to rule out serious causes.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - ASK DOCTOR SECTION

Stop and ask a doctor it:

  • Symptoms worsen or continue for more than 48 hours
  • There is discharge from the ear.
  • A fever of greater than 102° is present

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - DO NOT USE SECTION

Do not use: if you have ear drainage, irritation, discharge, or rash in the ear, consult a physician. With ear tubes, with damaged ear drums or after surgery. if drops become cloudy.

Directions

DOSAGE & ADMINISTRATION SECTION

Suitable for adults and children over the age of 2.

• For use in the ears only

• Remove any hearing aids

• Use 3-5 drops twice per day or as needed. Warm contents to body temperature by holding bottle in your hands. Tilt ear upward for at least 2 minutes after application or gently place cotton in ear to keep drops in. Tilt your head to the side and let solution drip into the ear. Never put the tip in the ear canal. Keep drops in your ear by tilting your head for 1-2 minutes or gently place cotton in the ear to keep drops in.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride, Citric Acid, Glycerine, Purified Water

Questions or comments?

OTC - QUESTIONS SECTION

(800) RITE-AID

(800-748-3243)

Other Information:

SPL UNCLASSIFIED SECTION

Active ingredients are microdiluted in accordance with the Homeopathic Pharmacopeia of the United States and are therefore non-toxic with no known side effects.

STORAGE AND HANDLING SECTION

• Store at 15°C-30°C (59°F-86°F)
• Protect from light and excessive moisture

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11822-3644-3

ear care

earache drops

homeopathic


eases pain

calms and soothes

relieves itching due to

cold & flu, swimmers

ear & allergy

0.33 FL. OZ. (10 mL)

External boxExternal box

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130011822364430GTIN-13: 0011822364430
EAN-13: 0011822364430
GTIN-12: 011822364430
UPC-A: 011822364430
GTIN storage (14 digits): 00011822364430
RA_Earache Drops_R1017.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3644-3EAR CARE EARACHE DROPS10 mL in 1 BOTTLE, DROPPERLIQUID102
11822-3644-3EAR CARE EARACHE DROPS1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3644EAR CARE EARACHE DROPS (ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFUR) LIQUID [RITE AID CORPORATION]2Current NDC, Legacy NDC, 2 package rows20180316_58f1f79f-f1dd-3094-e053-2991aa0ac591.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-364411822-3644-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
EAR CARE EARACHE DROPSATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFURRite Aid Corporation58f1f79f-f1dd-3094-e053-2991aa0ac5912018-03-16WarningsExact identifier
ndc (package): 11822-3644-3
ndc (product): 11822-3644
ndc11 (package): 11822364403
spl id: 678c8e7e-1d5b-f12a-e053-2991aa0ab6cc
spl set id: 58f1f79f-f1dd-3094-e053-2991aa0ac591

Reported adverse events (FAERS/openFDA)#

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