Label: NEUTRAPHOR- 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 November 19, 2010

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Dimethicone 1%

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects and helps relieve chapped or cracked skin
    • temporarily protects minor
      • cuts
      • scrapes
      • burns
  • Warnings

    For external use only

    When Using This Product

    • Keep out of eyes. Rinse eyes thoroughly with water to remove.

    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

    Do Not Use On

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep Out Of Reach Of Children

    • If swallowed, get medical help or contact a Poison Control Center right away
  • Directions

    Apply cream liberally as often as needed

  • Inactive Ingredients

    Water, Mineral Oil, White Petrolatum, Ceresin, Sorbitan Sesquioleate, Sorbitol, Lanolin Alcohol, Aluminum Hydroxide, Magnesium Hydroxide, BHT Ethylhexylglycerin, Phenoxyethanol

  • Questions?

    9a-5p weekdays M-F CST 1-877-725-7274

  • SPL UNCLASSIFIED SECTION

    Distributed by
    GinJen
    Hammond, LA 70401

  • PRINCIPAL DISPLAY PANEL - 57 g jar label

    PATENTED

    Smooth,
    Soothing,
    Cooling Cream
    for Skin
    Affected
    by Incontinence
    and Inactivity

    NEW

    DEVELOPED BY A PHYSICIAN
    NeutrapHor®
    SKIN PROTECTANT CREAM
    Long Term Relief

    pH-Mediated

    CLINIC

    FRAGRANCE FREE

    Distributed by
    GinJen
    Hammond, LA 70401
    1-877-725-7274

    Patent 6805875
    Patents Pending

    2.0 oz (57 g)
    www.neutraphor.com

    Principal Display Panel - 57 g jar label
  • INGREDIENTS AND APPEARANCE
    NEUTRAPHOR   SKIN PROTECTANT
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50952-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone0.57 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    Sorbitol (UNII: 506T60A25R)  
    Lanolin Alcohols (UNII: 884C3FA9HE)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Magnesium Hydroxide (UNII: NBZ3QY004S)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50952-002-0157 g in 1 JAR
    2NDC:50952-002-024 in 1 BOX
    257 g in 1 JAR
    3NDC:50952-002-0312 in 1 BOX
    357 g in 1 JAR
    4NDC:50952-002-0410 in 1 BOX
    410 g in 1 PACKET
    5NDC:50952-002-0525 in 1 BOX
    510 g in 1 PACKET
    6NDC:50952-002-06100 in 1 BOX
    610 g in 1 PACKET
    7NDC:50952-002-07144 in 1 BOX
    710 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/25/2010
    Labeler - pH R&D LLC (833115764)