WALGREENS EARACHE DROPS: Homeopathic Product Information

WALGREENS EARACHE DROPS- belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens whole and sulfur liquid
Walgreen Company

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

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


“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Purpose

Belladonna — Fever
Calcarea carbonica — Throbbing ear pain
Chamomilla — Sleeplessness and irritability
Lycopodium — Ear pain Pulsatilla — Ear itching, pain worse at night
Sulphur — 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 “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 eyes. • Do not take by mouth. • 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 accidental contact with eyes occurs, flush eyes with water and consult a doctor.

• 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 102o F is present.

Directions

Directions

Suitable for adults and children overtheageof2.•Forusein the ears only. • Remove any hearing aids before using this product. • Use 3 to 5 drops four times 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.

Other 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 o C — 30 o C (59 o F-86 o F ). • Protect from light and excessive moisture.

Inactive ingredients

Benzalkonium chloride, Citric acid, Glycerin, Purified water.

Questions or comments?

• 1-800-925-4733 • 9am– 5pm EST Monday — Friday

PRINCIPAL DISPLAY PANEL

Carton
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Label
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WALGREENS EARACHE DROPS
belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3233
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BELLADONNA LEAF (BELLADONNA LEAF) BELLADONNA LEAF 30 [hp_C] in 1 mL
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 30 [hp_C] in 1 mL
CHAMOMILE (CHAMOMILE) CHAMOMILE 30 [hp_C] in 1 mL
LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 30 [hp_C] in 1 mL
ANEMONE PATENS WHOLE (ANEMONE PATENS WHOLE) ANEMONE PATENS WHOLE 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:0363-3233-15 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0363-3233-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 06/22/2021
Labeler — Walgreen Company (008965063)

Revised: 02/2023 Walgreen Company

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