Earache

Manufacturer
CVS Pharmacy | Apotheca Company
Effective date
2020-04-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:13:07

Label at a glance#

ProductEarache
Active ingredientATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, SULFUR
Label structure11 sections

Indications and uses

•For use in the ears only.  According to homeopathic indications these ingredients temporarily relieve the symptoms of temperature above normal, discomfort, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common discomfort and itching of "swimmer's ear". *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administr...

Dosage and administration

Suitable for adults and children over the age of 2. • For use in the ears only. • Remove any hearing aids before using this product. • Use 3 to 5 drops twice per day or as needed. • 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 1-2 minutes or ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Belladonna 30C HPUS.........................Temperature above normal

Calcarea Carbonica 30C HPUS.............Burning Ear

Chamomilla 30C HPUS.......................Sleeplessness and irritability

Lycopodium Clavatum 30C HPUS.......Ear discomfort

Pulsatilla (Vulgaris) 30C HPUS............Ear itching, discomfort at night

Sulphur 30C HPUS............................Throbbing ear

The letter HPUS indicate that the components of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

USES*:

OTC - PURPOSE SECTION

•For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of temperature above normal, discomfort, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common discomfort and itching of "swimmer's 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 the eyes. 

• This product is intended to complement, not replace standard medical treatment. • Initial worsening of the symptoms may occur. 

• A physician should always be consulted to rule out serious causes. 

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

• Keep out of the reach of children. 

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

Do not use

• If you have ear drainage, irritation, discharge or rash in the ear, consult a physician.

• With ear tubes, damaged ear drums or after surgery.

• If drops become cloudy.

 Stop use and ask a doctor if

• Symptoms worsen or continue for more than 48 hours.

• There is discharge from the ear.

• A fever greater than 102°F is present.

OTHER SAFETY INFORMATION:

OTHER SAFETY INFORMATION

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.

• Store at 15°C-30°C (59°F-86°F).

• Protect from light and excessive moisture.

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

DO NOT USE:

OTC - DO NOT USE SECTION

DO NOT USE IF INPRINTED SEAL ON CAP IS TORN, BROKEN OR MISSING.

KEEP OUT OF REACH OF CHILDREN:

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Suitable for adults and children over the age of 2.

• For use in the ears only.

• Remove any hearing aids before using this product.

• Use 3 to 5 drops twice per day or as needed.

• 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 1-2 minutes or gently place cotton in the ear to keep drops in.

INDICATIONS:

INDICATIONS & USAGE SECTION

•For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of temperature above normal, discomfort, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common discomfort and itching of "swimmer's ear". *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

benzalkonium chloride, citric acid, glycerin, purified water

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by: CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

©2020 CVS/Pharmacy

CVS.com

1-800-SHOP CVS

V-19655

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS

Health

Compare to the

active ingredients in

Hyland's® Earache Drops

NDC 59779-568-15

Homeopathic

EarAche

EAR DROPS

• Relieves discomfort,

   calms irritability*

• Soothes itching due to

   cold, swimmer's ear

& allergy*

Package Contains 

One Bottle

0.33 FL OZ (10mL)

Earache LBLEarache LBL

Earache CTNEarache CTN

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-568-152022-01-28C16284748780-19d75b9d0-33fa-f424-e053-dadaa90a57ceDrug Facts:
59779-568-152020-04-20C16284748780-19d75b9d0-33fa-f424-e053-dadaa90a57ceDrug Facts:
59779-568-152020-01-31C16284748780-19d75b9d0-33fa-f424-e053-dadaa90a57ceDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-568-15Earache10 mL in 1 BOTTLE, DROPPERLIQUID104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-568EARACHE (BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SULPHUR) LIQUID [CVS PHARMACY]4Legacy NDC, 1 package rows20200430_e9767a0e-3456-4805-9169-35852cfe5bb3.zip

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
59779-56859779-568-15

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 · Source PDF

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
2f5779bc-e11c-4ac1-b793-63e5f4c25d5fe9767a0e-3456-4805-9169-35852cfe5bb32020-04-29WarningsExact identifier
spl id: 2f5779bc-e11c-4ac1-b793-63e5f4c25d5f
spl set id: e9767a0e-3456-4805-9169-35852cfe5bb3

Reported adverse events (FAERS/openFDA)#

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