Novana Wash Perineal Skin Cleanser
FDA Label NDC 76077-100

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 Wash Perineal Skin Cleanser (NDC 76077-100). 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, indications & usage, inactive ingredient, dosage & administration, 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                                                                        PurposeBenzethonium Chloride 0.1 %......................................................Antiseptic

Otc - Purpose

Uses For skin irritation due to incontinence. Protects against the risk of bacterial contamination in minor cuts, scrapes, and burns. Aids in the cleanup of urine and feces. Helps to remove barrier cream from skin.

Warnings

Warnings
For external use only.
When using this product • Do not get into eyes. • If contact occurs, rinse eyes thoroughly with water. Stop use and ask doctor if • if skin irritation and redness develop.



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.

Indications & Usage

Directions Cleanse the affected area according to protocol.

Inactive Ingredient

Inactive ingredients Water, Sodium Laureth Sulfate, Polyquaternium-7, Phenoxyethanol, Iodopropynyl Butylcarbamate

Dosage & Administration

Protocol: Shake well before use. Cleansing: Spray on the affected perineal area and remove with a moist washcloth. Aids in the removal of urine, feces and other foreign material. Ostomyl/Incontinence Appliance: To help control odor, spray into appliance before and after use.

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