Auro®

Auro®
SPL v1
SPL
SPL Set ID e5a21e5c-75c8-4ccd-8a3d-919ea0078063
Route
AURICULAR (OTIC)
Published
Effective Date 2010-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Matricaria Recutita (4 mL) Plantago Major (0.3256 mL) Verbascum Thapsus Atropa Belladonna Chili Pepper Oyster Shell Calcium Carbonate, Crude Potassium Cation
Inactive Ingredients
Citric Acid Monohydrate Glycerin Water Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2010-06-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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
Section 53414-9

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

Section 55105-1
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
Warnings

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

Questions

call 1-800-344-7239

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. 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

citric acid, glycerin, purified water, sodium benzoate

Principal Display Panel 29.6 Ml Bottle Carton

AURO ®

EARACHE RELIEF

EAR DROPS

HOMEOPATHIC

RELIEVES EARACHE PAIN

  • CALMS & SOOTHES
  • SAFE & EFFECTIVE FOR

    ADULTS & CHILDREN

1 FL OZ (29.6 mL)


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
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
Warnings

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

Questions

call 1-800-344-7239

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. 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 (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 (Inactive ingredients)

citric acid, glycerin, purified water, sodium benzoate

Principal Display Panel 29.6 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton)

AURO ®

EARACHE RELIEF

EAR DROPS

HOMEOPATHIC

RELIEVES EARACHE PAIN

  • CALMS & SOOTHES
  • SAFE & EFFECTIVE FOR

    ADULTS & CHILDREN

1 FL OZ (29.6 mL)


Advanced Ingredient Data


Raw Label Data

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