Label: NEUTRAPHORUS REX 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 November 13, 2012

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?

    M-F 9a-5p CST

    1-877-725-7274

  • PRINCIPAL DISPLAY PANEL - 57 g Jar

    DEVELOPED BY A PHYSICIAN

    FRAGRANCE FREE

    NEW

    NeutrapHorus
    Rex
    ® SKIN PROTECTANT CREAM

    Smooth, Soothing, Cooling Cream
    pH-Mediated

    2.0 oz (57 g)

    Distributed by
    pH R&D
    Hammond, LA 70401

    1-877-725-7274

    Patent 6805875
    Patents Pending

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    NEUTRAPHORUS REX  SKIN PROTECTANT
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50952-003
    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)  
    Ceresin (UNII: Q1LS2UJO3A)  
    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:50952-003-0157 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/22/2010
    Labeler - pH R&D LLC (833115764)