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

Auro Homeopathic Ear Relief Drops by

Drug Labeling and Warnings

Auro Homeopathic Ear Relief Drops by is a Homeopathic medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

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)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-326-26	1 in 1 CARTON
1		29.6 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		11/15/2013

Labeler - Insight Pharmaceuticals (176792315)