EAR CARE EARACHE DROPS: Homeopathic Product Information

EAR CARE EARACHE DROPS- atropa belladonna, oyster shell calcium carbonate, crude, matricaria chamomilla, lycopodium clavatum spore, anemone pulsatilla and sulfur liquid
Rite Aid Corporation

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.

Drug Facts

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*

• 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

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.

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.

Inactive ingredients

Benzalkonium Chloride, Citric Acid, Glycerine, Purified Water

Questions or comments?

(800) RITE-AID

(800-748-3243)

Other Information:

Active ingredients are microdiluted in accordance with the Homeopathic Pharmacopeia 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

PRINCIPAL DISPLAY PANEL — 10 mL Bottle Carton

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 box
(click image for full-size original)
EAR CARE EARACHE DROPS
atropa belladonna, anemone pulsatilla, lycopodium clavatum spore, matricaria chamomilla, and sulfur liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-3644
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 30 [hp_C] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE) OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C] in 1 mL
MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 30 [hp_C] in 1 mL
LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 30 [hp_C] in 1 mL
ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 30 [hp_C] in 1 mL
SULFUR (SULFUR) SULFUR 30 [hp_C] in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
WATER
BENZALKONIUM CHLORIDE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-3644-3 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (11822-3644-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 08/03/2017
Labeler — Rite Aid Corporation (014578892)

Revised: 03/2018 Rite Aid Corporation

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