Ear Care Earache Drops

ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, and SULFUR · Liquid · Auricular (otic)

Over the counter 1 recall

Active ingredient

Active ingredients Purpose "HPUS" indicates the components of this product are officially monographed in the Homeopathic Pharmacopœia of the United States. Belladonna 30C HPUS Fever Calcarea Carbonica 30C HPUS Throbbing ear pain Chamomilla 30C HPUS Sleeplessness and irritability Lycopodium 30C HPUS Ear pain Pulsatilla 30C HPUS Ear itching, pain worse at night Sulphur 30C HPUS Ear pain with burning

Purpose

Active ingredients Purpose "HPUS" indicates the components of this product are officially monographed in the Homeopathic Pharmacopœia of the United States. Belladonna 30C HPUS Fever Calcarea Carbonica 30C HPUS Throbbing ear pain Chamomilla 30C HPUS Sleeplessness and irritability Lycopodium 30C HPUS Ear pain Pulsatilla 30C HPUS Ear itching, pain worse at night Sulphur 30C HPUS Ear pain with burning

Uses

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.

Warnings

Warnings 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. If pregnant or breast feeding, ask a health professional before use. 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 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, with damaged ear drums or after surgery. if drops become cloudy.

Do not use

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.

Ask a doctor before use

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

Pregnancy or breast-feeding

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

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

Directions 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.

Other information

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

Inactive ingredients

Inactive ingredients Benzalkonium Chloride, Citric Acid, Glycerine, Purified Water

Questions?

Questions or comments? (800) RITE-AID (800-748-3243)

Label text from the FDA structured product label by Rite Aid Corporation (revised Mar 16, 2018). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Ear Care Earache Drops NDC products (1)

NDCStrength & formLabelerType
11822-3644Atropa Belladonna 30 [hp_C]/mL; Oyster Shell Calcium Carbonate, Crude 30 [hp_C]/mL; Matricaria Chamomilla 30 [hp_C]/mL;…
Liquid
Rite Aid CorporationUNAPPROVED HOMEOPATHIC

Ear Care Earache Drops recalls

Frequently asked questions

What is Ear Care Earache Drops used for?

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.

Who makes Ear Care Earache Drops?

Ear Care Earache Drops is listed by 1 labeler in the FDA NDC directory, including Rite Aid Corporation.

Has Ear Care Earache Drops been recalled?

The FDA enforcement database lists 1 recall for Ear Care Earache Drops, most recently D-0989-2022 (class ii): Microbial contamination of non-sterile product.