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.

----------

AURO®
EARACHE RELIEF
EAR DROPS

Drug Facts

Active ingredientsPurpose
Chamomilla (Chamomile)
1X, 6X, 12X, 30X
calmative
Plantago major (Plantain) 4Xpain 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 agetilt 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 ageconsult 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

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63736-324
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA4 mL  in 30 mL
PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR0.3256 mL  in 30 mL
VERBASCUM THAPSUS (VERBASCUM THAPSUS) VERBASCUM THAPSUS0.3256 mL  in 30 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA0.3256 mL  in 30 mL
CHILI PEPPER (CHILI PEPPER) CHILI PEPPER0.3256 mL  in 30 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE) OYSTER SHELL CALCIUM CARBONATE, CRUDE0.3256 mL  in 30 mL
POTASSIUM DICHROMATE (POTASSIUM CATION) POTASSIUM DICHROMATE0.3256 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
WATER 
SODIUM BENZOATE 
Product Characteristics
ColorWHITE (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-324-2424 in 1 CASE
11 in 1 BOX
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic06/01/2010
Labeler - Insight Pharmaceuticals (176792315)

Revised: 6/2010
Document Id: 67d0e4a6-91ac-4aac-bc2d-87cbc131529a
Set id: e5a21e5c-75c8-4ccd-8a3d-919ea0078063
Version: 1
Effective Time: 20100623
 
Insight Pharmaceuticals