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Name:Auro Earache Relief
Manufacturer:Insight Pharmaceuticals
Category:Homeopathic Marketed Drugs


AURO® EARACHE RELIEF EAR DROPS

AURO EARACHE RELIEF - matricaria recutita, plantago major, verbascum thapsus, atropa belladonna, chili pepper, oyster shell calcium carbonate, crude and potassium dichromate liquid 
Insight Pharmaceuticals

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®
EARACHE RELIEF
EAR DROPS

Drug Facts

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

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

Warnings

Do not take by mouth. Earache 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. 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

Questions

call 1-800-344-7239

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

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)

Principal Display Panel

AURO EARACHE RELIEF 
matricaria recutita, plantago major, verbascum thapsus, atropa belladonna, chili pepper, oyster shell calcium carbonate, crude, and potassium dichromate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-324
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 4 mL  in 30 mL
PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR 0.3256 mL  in 30 mL
VERBASCUM THAPSUS (VERBASCUM THAPSUS) VERBASCUM THAPSUS 0.3256 mL  in 30 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 0.3256 mL  in 30 mL
CHILI PEPPER (CHILI PEPPER) CHILI PEPPER 0.3256 mL  in 30 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE) OYSTER SHELL CALCIUM CARBONATE, CRUDE 0.3256 mL  in 30 mL
POTASSIUM DICHROMATE (POTASSIUM CATION) POTASSIUM DICHROMATE 0.3256 mL  in 30 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
GLYCERIN  
WATER  
SODIUM BENZOATE  
Product Characteristics
Color WHITE (Clear) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-324-24 24 BOX ( BOX) in 1 CASE contains a BOX
1 1 BOTTLE ( BOTTLE) in 1 BOX This package is contained within the CASE (63736-324-24) and contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within a BOX and a CASE (63736-324-24)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved homeopathic 06/01/2010

Labeler - Insight Pharmaceuticals (176792315)

Revised: 06/2010 Insight Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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