AURO ® EARACHE RELIEF EAR DROPS

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
Chamomilla (Chamomile) 1X, 6X, 12X, 30X	calmative
Plantago major (Plantain) 4X	pain reliever
Verbascum thapsus (Mullein) 4X	pain reliever
Belladonna (Nightshade) 6X, 12X, 30X	anti-inflammatory
Capsicum annuum (Cayenne) 6X	anti-inflammatory
Calcarea carbonica (Calcium carbonate) 12X	pain reliever
Kali bichromicum (Potassium dichromate) 12X	pain reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain, discomfort, and irritability associated with earaches in adults and children, after diagnosis by a doctor

Warnings

WARNINGS SECTION

Do not take by mouth. Earache drops are only to be used in the ears. Do not use with ear tubes.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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. 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

citric acid, glycerin, purified water, sodium benzoate

Questions

OTC - QUESTIONS SECTION

call 1-800-344-7239

SPL UNCLASSIFIED SECTION

Distributed by:
INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AURO^®
EARACHE RELIEF

EAR DROPS

HOMEOPATHIC

RELIEVES EARACHE PAIN

• CALMS & SOOTHES
• SAFE & EFFECTIVE FOR
  ADULTS & CHILDREN

1 FL OZ (29.6 mL)

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

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DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

• Auro Earache Relief
• MATRICARIA RECUTITA, PLANTAGO MAJOR, VERBASCUM THAPSUS, ATROPA BELLADONNA, CHILI PEPPER, OYSTER SHELL CALCIUM CARBONATE, CRUDE, and POTASSIUM DICHROMATE
• MATRICARIA RECUTITA
• PLANTAGO MAJOR
• VERBASCUM THAPSUS
• ATROPA BELLADONNA
• CHILI PEPPER
• OYSTER SHELL CALCIUM CARBONATE, CRUDE
• POTASSIUM DICHROMATE
• POTASSIUM CATION
• CITRIC ACID MONOHYDRATE
• GLYCERIN
• WATER
• SODIUM BENZOATE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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Inactive ingredient matches#

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Inactive ingredient links page 1 of 4 · 198 matching rows.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

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Adverse event summaries are temporarily unavailable. Other product information remains available.