FDA Label for Novana All-in-one One Step Perineal

View Indications, Usage & Precautions

Novana All-in-one One Step Perineal Product Label

The following document was submitted to the FDA by the labeler of this product Novana Medical Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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