FDA Label for Walgreens Earache Drops
View Indications, Usage & Precautions
Walgreens Earache Drops Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
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.
Otc - Pregnancy Or Breast Feeding
• If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
Otc - Do Not Use
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.
Otc - Stop Use
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?
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