Auro Earache Relief
FDA Label NDC 63736-324

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals for the product Auro Earache Relief (NDC 63736-324). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding uses, warnings, otc - stop use, otc - pregnancy or breast feeding, directions, other information, inactive ingredients, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 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

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)

    Principal Display Panel (Auro 01)

    Principal Display Panel (Auro 01)

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