Novana All-in-one One Step Perineal
FDA Label NDC 76077-500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Novana Medical Llc for the product Novana All-in-one One Step Perineal (NDC 76077-500). 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, warnings, otc - keep out of reach of children, dosage & administration, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                                                                     Purpose
Dimethicone 2%.......................................................................................................Skin Protectant


Otc - Purpose

Uses Temporarily protects and helps relieve chapped or cracked skin.

Warnings

Warnings
For external use only.
When using this product • Avoid contact with eyes • Stop use and ask doctor if  • If condition worsens  •symptoms last more than 7 days or clear up and occur again within a few days. Do not use on  •deep or puncture wounds  •animal bites  •serious burns.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

For external use only.

Indications & Usage

Directions •Apply as needed. • Change wet and soiled undergarments. • Apply to affected area and gently wipe with clean, soft cloth. • Use with each undergarment change, especially at bedtime or any time when exposure to wet garments may be prolonged.

Inactive Ingredient

Inactive ingredients
Water, Cetyl Alcohol, Stearyl Alcohol, Glycine Soja (Soybean) Oil, Propanediol, Polysorbate 60,
Panthenol, Glycerin, Isopropyl Myristate, Allantoin, Tocopherol, Sodium Laureth Sulfate, Citric Acid,
Phenoxyethanol, Iodopropynyl Butylcarbamate

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