FDA Label for Auro Earache Relief
View Indications, Usage & Precautions
Auro Earache Relief Product Label
The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Otc - Stop Use
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
If pregnant or breast-feeding ask a doctor before use.
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
Other
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)
* Please review the disclaimer below.