DOLOEAR- atropa belladonna, apis mellifera, aristolochia clematitis root, matricaria recutita, lachesis muta venom, and thuja oc

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H), APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z), ARISTOLOCHIA CLEMATITIS ROOT (UNII: ZY0NX0W00D) (ARISTOLOCHIA CLEMATITIS ROOT - UNII:ZY0NX0W00D), MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ), LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I), THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)
Available from:
Pharmadel LLC
Administration route:
AURICULAR (OTIC)
Prescription type:
OTC DRUG
Therapeutic indications:
For the temporary relief of earache associated with cold and flu, sore throat, swimmer's ear, sinusitis or wax build up.
Authorization status:
unapproved homeopathic
Authorization number:
55758-001-15

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™

Drug Facts

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

Thuja occidentalis 6C

Otalgia with noises in

ears

Us es

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)

DOLOEAR

atropa belladonna, apis mellifera, aristolochia clematitis root, matricaria recutita, lachesis muta venom, and thuja

occidentalis leafy twig solution/ drops

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55758 -0 0 1

Route of Administration

AURICULAR (OTIC)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

®

Pharmadel LLC

ATRO PA BELLADO NNA (UNII: WQZ3G9 PF0 H) (ATROPA BELLADONNA -

UNII:WQZ3G9 PF0 H)

ATROPA BELLADONNA

6 [hp_C]

in 15 mL

APIS MELLIFERA (UNII: 7S8 2P3R43Z) (APIS MELLIFERA - UNII:7S8 2P3R43Z)

APIS MELLIFERA

6 [hp_C]

in 15 mL

ARISTO LO CHIA CLEMATITIS RO O T (UNII: ZY0 NX0 W0 0 D) (ARISTOLOCHIA

CLEMATITIS ROOT - UNII:ZY0 NX0 W0 0 D)

ARISTOLOCHIA

CLEMATITIS ROOT

6 [hp_C]

in 15 mL

MATRICARIA RECUTITA (UNII: G0 R4UBI2ZZ) (MATRICARIA RECUTITA -

UNII:G0 R4UBI2ZZ)

MATRICARIA RECUTITA

6 [hp_C]

in 15 mL

LACHESIS MUTA VENO M (UNII: VSW71SS0 7I) (LACHESIS MUTA VENOM -

UNII:VSW71SS0 7I)

LACHESIS MUTA VENOM

6 [hp_C]

in 15 mL

THUJA O CCIDENTALIS LEAFY TWIG (UNII: 1NT28 V9 39 7) (THUJA OCCIDENTALIS

LEAFY TWIG - UNII:1NT28 V9 39 7)

THUJA OCCIDENTALIS

LEAFY TWIG

6 [hp_C]

in 15 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:55758 -0 0 1-

15 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

11/15/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 5/23/20 13

Labeler -

Pharmadel LLC (030129680)

Registrant -

HomeoCare Laboratories, Inc. (088248828)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho meo Care Labo rato ries, Inc.

0 8 8 248 8 28

ma nufa c ture (55758 -0 0 1)

Revised: 11/2019

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