Oido Sana Solution
FDA Label NDC 58988-1100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Promex Llc for the product Oido Sana (NDC 58988-1100). 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 other, otc - purpose, uses, warnings, ask a doctor before use if you have, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

Otc - Purpose

Active Ingredients:Purpose
Isopropyl alcohol 95%Ear drying aid
Anhydrous glycerin 5% baseEar drying aid

Uses

dries water in the ears

Warnings

Flammable: Keep away from fire and flame

Use only in a well ventilated area; fumes may be toxic.

Ask A Doctor Before Use If You Have

  • Ear drainage or discharge
  • Pain, irritation or rash in the ear
  • Had ear surgery
  • Dizziness

Otc - Stop Use

Stop use and ask a doctor if irritation (too much burning) or pain occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

remove safety seal from bottle, apply 4 to 5 drops in each affected ear.

Other Information

  • Recap bottle after each use
  • Keep away from heat or direct sunlight
  • Store at room temperature
  • Do not use if safety seal is damaged or missing prior to first use

Principal Display Panel - 30 Ml Bottle Carton

OIDO® SANA

Pro-Mex®

Fast Relief for

Ears

1 fl oz (30 mL)

Principal Display Panel (30 mL Bottle Carton)

Principal Display Panel (30 mL Bottle Carton)

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