Label: GOODSTUFF 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 July 3, 2013

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  • 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 throughly 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

  • SPL UNCLASSIFIED SECTION

    Distributed by
    pH R&D GinJen
    Hammond, LA 70401

  • PRINCIPAL DISPLAY PANEL - 5 Packet Carton

    NDC 50952-009-11

    SKIN PROTECTANT CREAM

    Five Convenient 10ml Packets

    GOOD
    STUFF™
    TO GO

    Best darn tootin'
    temp'rary protection
    n' relief fer
    all yer parts in
    these parts fer minor
    irr'tated, red,
    cattle proddin', ,
    cuts n' scrapes,
    an' if
    a cow
    steps on
    yer leg.

    gitcha
    some

    Five 10ml (.35oz) Packets • Total Wt. 50g (grams)

    Principal Display Panel - 5 Packet Carton
  • INGREDIENTS AND APPEARANCE
    GOODSTUFF   SKIN PROTECTANT
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50952-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone10 mg  in 1 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:50952-009-0910 g in 1 PACKET
    2NDC:50952-009-1057 g in 1 JAR
    3NDC:50952-009-115 in 1 BOX
    350 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/26/2013
    Labeler - pH R&D LLC (833115764)
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