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Drug Facts
Ear Care Earache Drops Liquid
FDA Label NDC 11822-3644
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Ear Care Earache Drops (NDC 11822-3644). 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 other, otc - purpose, uses*, warnings, otc - pregnancy or breast feeding, otc - ask doctor, otc - keep out of reach of children, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Ask Doctor
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
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, 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.
Storage And Handling
• 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)
* Please review the disclaimer below.
