Walgreens Earache Drops

Walgreens Earache Drops
SPL v3
SPL
SPL Set ID c573dc3c-992e-604d-e053-2995a90a0ff4
Route
AURICULAR (OTIC)
Published
Effective Date 2021-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Belladonna Leaf (30 [hp_C]) Calcium Cation Chamomile Lycopodium Clavatum Spore Anemone Patens Whole Sulfur
Inactive Ingredients
Citric Acid Monohydrate Water Benzalkonium Chloride Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-06-22

Description

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


Medication Information

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

Description

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.

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.

Section 50565-1

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

Section 50566-9

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.

Section 50570-1

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.

Section 53414-9

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

Section 55106-9
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.

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.

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


Structured Label Content

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.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Section 55106-9 (55106-9)
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

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.

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 (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 (Inactive ingredients)

Benzalkonium chloride, Citric acid, Glycerin, Purified water.

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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