Oramedy
FDA Label NDC 72689-0039

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oasis Trading for the product Oramedy (NDC 72689-0039). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

For the treatment of chronic exfoliative gingivitis, obstinate stomatitis and glossitis with erosive and ulcerative lesions. For adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Apply a small dab to the lesion once to several times a day.

Warnings

For external use only.

Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator.

Ask a doctor before use if you have a vaginal discharge, rectal bleeding, diaper rash.

When using this product consult a doctor before exceeding recommended dosage.

Stop use and ask a doctor if condition gets worse, condition persists for more than 7 days, condition clears up and occurs again with within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredient

Sodium Carboxymethyl Cellulose, Sodium Polyacrylate, Pectin, Plastibase

Dosage & Administration

For buccal use only

Package Label.Principal Display Panel

1 (Ora)

1 (Ora)

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