AURO HOMEOPATHIC EAR RELIEF DROPS- atropa belladonna, oyster shell calcium carbonate, crude, capsicum, matricaria recutita, potassium dichromate, plantago major, and verbascum thapsus liquid
Insight Pharmaceuticals 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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Auro HOMEOPATHIC EAR RELIEF DROPS

Auro®Earache

Drug Facts

Active ingredients (in each drop)

Purpose

Belladonna 18X	hardness of hearing
Calcarea carbonica 12X	discomfort in ear
Capsicum annuum 6X	pressure in ear
Chamomilla 15X	calmative
Kali bichromicum 12X	tickling
Plantago major 4X	sensitivity to discomfort
Verbascum thapsus 4X	clogging

Uses

may help with the irritation of clogged ears by relieving the sense of discomfort in the ear, sensitivity to earwax and drafts.

Warnings

Do not take by mouth. Ear drops are only to be used in the ears.

Do not use with ear tubes.

Stop use and ask a doctor if

symptoms persist for more than 48 hours
there is discharge from the ear
there is a fever of 102°F or greater

If pregnant or breast-feeding

ask a doctor before use.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

for adults and children over 6 months of age	tilt head sideways and apply 3-4 drops into the affected ear up to 4 times daily. Tip of dropper should not enter ear canal. To keep drops in, tilt ear upward after application or gently place cotton in the ear.
children under 6 months of age	consult a doctor

Other information

Do not use if white neck band imprinted with "SEALED FOR YOUR PROTECTION" is broken or missing. Keep carton for full drug facts.

Inactive ingredients

chamomile (flower) extract, citric acid, glycerin, purified water, sodium benzoate

Questions?

call 1-800-344-7239

Distributed by: INSIGHT Pharmaceuticals, LLC.
Trevose, PA 19053-8433

PRINCIPAL DISPLAY PANEL

- 29.6 mL Bottle Carton

Auro®

Homeopathic*
Ear
Relief Drops

May help ease symptoms
of clogged ears
Long lasting relief
Safe for daily use
For children over 6 months

1FL OZ (29.6 mL)

PRINCIPAL DISPLAY PANEL
- 29.6 mL Bottle Carton
Auro®
Homeopathic*
Ear
Relief Drops
• May help ease symptoms
of clogged ears
• Long lasting relief
• Safe for daily use
• For children over 6 months
1FL OZ (29.6 mL)

AURO HOMEOPATHIC EAR RELIEF DROPS
atropa belladonna, oyster shell calcium carbonate, crude, capsicum, matricaria recutita, potassium dichromate, plantago major, and verbascum thapsus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63736-326
Route of Administration	AURICULAR (OTIC)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H)	Atropa Belladonna	18 [hp_X] in 0.05 mL
Oyster Shell Calcium Carbonate, Crude (UNII: 2E32821G6I) (Oyster Shell Calcium Carbonate, Crude - UNII:2E32821G6I)	Oyster Shell Calcium Carbonate, Crude	12 [hp_X] in 0.05 mL
Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG)	Capsicum	6 [hp_X] in 0.05 mL
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ)	Matricaria Recutita	15 [hp_X] in 0.05 mL
Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V)	Potassium Dichromate	12 [hp_X] in 0.05 mL
Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U)	Plantago Major	4 [hp_X] in 0.05 mL
Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172)	Verbascum Thapsus	4 [hp_X] in 0.05 mL

Ingredient Name	Strength
Inactive Ingredients
Chamomile (UNII: FGL3685T2X)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Sodium Benzoate (UNII: OJ245FE5EU)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63736-326-26	1 in 1 CARTON	11/15/2013	06/30/2019
1		29.6 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/15/2013	06/30/2019

Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 3/2023

Document Id: 88353f85-2581-4372-a83a-efb73c4d07cf

Set id: 788ccc23-2abf-48ce-9d97-9283980b18ec

Version: 3

Effective Time: 20230307

Insight Pharmaceuticals LLC