EARACHE- belladonna, calcarea carbonica, chamomilla, lycopodium clavatum, pulsatilla (vulgaris), sulphur liquid 
CVS Pharmacy

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

ACTIVE INGREDIENTS:

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*:

•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:

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:

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:

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

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

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:

•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:

benzalkonium chloride, citric acid, glycerin, purified water

QUESTIONS:

Distributed by: CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

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CVS.com

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V-19655

PACKAGE LABEL DISPLAY:

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 LBL

Earache CTN

EARACHE 
belladonna, calcarea carbonica, chamomilla, lycopodium clavatum, pulsatilla (vulgaris), sulphur liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-568
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA30 [hp_C]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_C]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-568-1510 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/22/2016
Labeler - CVS Pharmacy (062312574)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(59779-568) , api manufacture(59779-568) , label(59779-568) , pack(59779-568)

Revised: 4/2020
Document Id: 2f5779bc-e11c-4ac1-b793-63e5f4c25d5f
Set id: e9767a0e-3456-4805-9169-35852cfe5bb3
Version: 4
Effective Time: 20200429
 
CVS Pharmacy