Label: PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 7, 2019

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  • Drug Facts


  • 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

  • PRINCIPAL DISPLAY PANEL

    Pro ADVANTAGE Fast Absorbing by NDC
    Perineal Cream with Dimethicone
    4FL.OZ ( 118 mL )
    Skin Protectant

  • Product Labels

    Perineal Label 1Perineal Label 2

  • INGREDIENTS AND APPEARANCE
    PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43128-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALLANTOIN (UNII: 344S277G0Z)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43128-035-021 in 1 PACKAGE03/07/2013
    1118 mL in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/07/2013
    Labeler - NDC National Distribution & Contracting, Inc. (009831413)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dukal865792209manufacture(43128-035)
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