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 6CPain in ears, inflammation
Apis mellifica 6CPain in ears, inflammation
Aristolochia clematis 6CEar pain with tinnitus
Chamomilla 6CEarache, toothache
Lachesis mutus 6CEar pain with wax build up
Thuja occidentalis 6COtalgia 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.