FDA Label for Earache

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.

†These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

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 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:

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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†

0.33 FL OZ (10mL)