Pro Advantage Fast Absorbing Perineal With Dimethicone Skin Protectant
FDA Label NDC 43128-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ndc National Distribution & Contracting, Inc. for the product Pro Advantage Fast Absorbing Perineal With Dimethicone Skin Protectant (NDC 43128-035). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Dimethicone 2%
Purpose
Skin Protectant
Uses
Temporarily protects • and helps relieve chapped or cracked skin
Warnings
For external use only
Do Not Use
on • deep or puncture wounds • animal bites • serious burns
When Using This Product
• do not get into eyes
Stop Use And Ask A Doctor If
• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children.
• If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
• gently cleanse and dry affected area • apply liberally to affected area as needed.
Inactive Ingredients
Water, Mineral Oil, Glycerin, Propylene Glycol, Caprylic/Capric Triglyceride, Polysorbate 60, Cetyl Alcohol, Glyceryl Stearate, Sorbitan Stearate, Carbomer, Triethanolamine, Allantoin, Diazolidinyl Urea, Methylparaben, Propylparaben, Fragrance
Ref: P770035 Ndc 43128-035-03
Made in China
www.ProAdvantagebyNDC.com
Manufactured for NDC, Inc.
407 New Sanford Road, La Vergne, TN 37086
Package Label.Principal Display Panel
Pro ADVANTAGE Fast Absorbing by NDC
Perineal Cream with Dimethicone
4FL.OZ ( 118 mL )
Skin Protectant
Product Labels
Perineal Label 1 (Perineallabel1)
Perineal Label 2 (Perineallabel2)
* Please review the disclaimer below.
