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.
Otc - Purpose
Active Ingredients** (HPUS) | Purposes* |
---|---|
Apis melifica 6C ....................... | Ear pain, inflammation |
Aristolochia clematitis 6C......... | Earache inflammation |
Belladonna 6C.......................... | Throbbing pain |
Chamomilla vulgaris 6C .......... | Ear pain irritability |
Lachesis mutus 6C .................. | Ear inflammation |
Thuja occidentalis 6C .............. | Earache from pressur |
The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.
Uses*
Temporarily relieves earache symptoms associated with
- common pain and itching of swimmer's ear
- clogged ears
- ear pain or itching from other earaches after diagnosis by a doctor
Warnings
For use in ears only.
Do Not Use
if you have ear tubes, a damaged eardrum, or after surgery
Stop Use And Ask Your Doctor If
- symptoms persist for more than 48 hours or worsen
- symptoms are accompanied by a fever
- any discharge from the ear is present
If Pregnant Or Breatfeeding,
seek professional advice before taking this product.
Keep Out Of The Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
- shake before use
- tilt head sideways and apply 2-3 drops into the ear (tip of dropper should not enter the ear canal)
- keep head tilted and allow drops to remain in the ear for 2 minutes or gently place cotton in ear to keep drops in
- repeat as needed, up to 4 times a day
adults and children ages 6 and older:
Other Information
- store in a cool dry place
- do not use if neckband seal is torn, broken, or missing
Inactive Ingredients
castor oil
Questions, Comments?
1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Homeopathic Statements
*These “USES” claims have not been evaluated by the Food and Drug Administration (FDA). They are based on traditional homeopathic practices.
**C, K, CK and X are homeopathic dilutions.
* Please review the disclaimer below.