DOLOEAR- apis melifica, aristolochia clematitis, belladonna, chamomilla, lachesis mutus, thuja occidentalis 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]

Drug Facts

Active ingredients & Purposes

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

adults and children ages 6 and older:

• 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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOLOEAR 
apis melifica, aristolochia clematitis, belladonna, chamomilla, lachesis mutus, thuja occidentalis solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-401
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
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
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [hp_C]  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-401-15	1 in 1 BOX	09/07/2023
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/07/2023

Labeler - Pharmadel LLC (030129680)