DOLOEAR- atropa belladonna, apis mellifera, aristolochia clematitis root, matricaria recutita, lachesis muta venom, and thuja occidentalis leafy twig solution/ drops 
Pharmadel LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DoloEar (Homeocare)

Drug Facts

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.

Do not use if you have: ear drainage, discharge, dizziness, ear tubes, damaged ear drum, or fever of 102 or greater.

Consult a physician before use: if pregnant or breastfeeding, in children under 2 years of age.

Stop use and ask your doctor: if symptoms worsen, reoccur, or persist for more than 48 hours, or if fever develops.

Keep out of the reach of children

Do not use if neckband is missing or broken

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

Distributed by:
PHARMADEL LLC. ®
Seaford, DE 19973

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)

PRINCIPAL DISPLAY PANEL - 15mL Bottle Label
DOLOEAR 
atropa belladonna, apis mellifera, aristolochia clematitis root, matricaria recutita, lachesis muta venom, and thuja occidentalis leafy twig solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-001
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_C]  in 15 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_C]  in 15 mL
ARISTOLOCHIA CLEMATITIS ROOT (UNII: ZY0NX0W00D) (ARISTOLOCHIA CLEMATITIS ROOT - UNII:ZY0NX0W00D) ARISTOLOCHIA CLEMATITIS ROOT6 [hp_C]  in 15 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]  in 15 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM6 [hp_C]  in 15 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_C]  in 15 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-001-1515 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/23/2013
Labeler - Pharmadel LLC (030129680)

Revised: 12/2021
Document Id: d21a2c9d-1a4b-b53a-e053-2a95a90a177f
Set id: 677c111f-513b-4148-a954-2a801fa4ebcf
Version: 3
Effective Time: 20211201
 
Pharmadel LLC