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

DoloEar by

Drug Labeling and Warnings

DoloEar by is a Homeopathic medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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.

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

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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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-001
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_C]  in 15 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_C]  in 15 mL
ARISTOLOCHIA CLEMATITIS ROOT (UNII: ZY0NX0W00D) (ARISTOLOCHIA CLEMATITIS ROOT - UNII:ZY0NX0W00D)	ARISTOLOCHIA CLEMATITIS ROOT	6 [hp_C]  in 15 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_C]  in 15 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	6 [hp_C]  in 15 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	6 [hp_C]  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-001-15	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/23/2013

Labeler - Pharmadel LLC (030129680)

Registrant - HomeoCare Laboratories, Inc. (088248828)

Establishment
Name	Address	ID/FEI	Business Operations
HomeoCare Laboratories, Inc.		088248828	manufacture(55758-001)