FDA Label for Doloear
View Indications, Usage & Precautions
Doloear Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. 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.
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Drug Facts
Distributed by:
PHARMADEL LLC.®
Seaford, DE 19973
Otc - Purpose
Active Ingredients HPUS: | Purpose |
---|---|
Belladonna 6C | Pain in ears, inflammation |
Apis mellifica 6C | Pain in ears, inflammation |
Aristolochia clematis 6C | Ear pain with tinnitus |
Chamomilla 6C | Earache, toothache |
Lachesis mutus 6C | Ear pain with wax build up |
Thuja occidentalis 6C | Otalgia with noises in ears |
Uses
For the temporary relief of earache associated with cold and flu, sore throat, swimmer's ear, sinusitis or wax build up.
Warnings
For use in ears only.
Otc - Do Not Use
Do not use if you have: ear drainage, discharge, dizziness, ear tubes, damaged ear drum, or fever of 102 or greater.
Do not use if neckband is missing or broken
Otc - Ask Doctor
Consult a physician before use: if pregnant or breastfeeding, in children under 2 years of age.
Otc - Stop Use
Stop use and ask your doctor: if symptoms worsen, reoccur, or persist for more than 48 hours, or if fever develops.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children
Directions
Adults and children: Remove tamper-evident neckband from bottle. Shake bottle before each use. Tilt head sideways and apply 2-3 drops into ear (to preserve purity, prevent tip of dropper from touching ear.) Allow drops to remain in ear by keeping head tilted or placing cotton in ear. Repeat as needed.
Inactive Ingredients
Glycerin USP, DI water.
Questions, Comments?
call 1-866-359-3478 M-F 9 AM to 5 PM Eastern Time
Principal Display Panel - 15Ml Bottle Label
DoloEar™
Homeopathic Ear Drops
For the temporary relief of:
earache associated
with cold and flu,
sore throat,
swimmer's ear,
sinusitis or
wax build up.
0.50 FL OZ (15mL)
* Please review the disclaimer below.