Hydrocortisone And Acetic Acid Solution
FDA Label NDC 71656-064

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Saptalis Pharmaceuticals, Llc for the product Hydrocortisone And Acetic Acid (NDC 71656-064). 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 package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package/Label Principal Display Panel

NDC 71656-064-10

Hydrocortisone and Acetic Acid Otic Solution, USP

1% / 2%

For Otic Use Only

Rx only

10 mL

Label (Image1)

Label (Image1)

NDC 71656-064-10

Hydrocortisone and Acetic Acid Otic Solution, USP

1% / 2%

For Otic Use Only.

Rx only

10 mL

Carton (Image02)

Carton (Image02)

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