The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Walgreens Earache Drops (NDC 0363-3233). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpose, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
| 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.
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*
• 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.
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
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.
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.
Benzalkonium chloride, Citric acid, Glycerin, Purified water.
• 1-800-925-4733 • 9am– 5pm EST Monday - Friday
Carton (Wag Ee 201994 Earachedrops Box)
Label (Wag Ee 201994 Earachedrops Lab)
* Please review the disclaimer below.
