Label: GOODSTUFF  SKIN PROTECTANT- dimethicone cream 

  • Label RSS
  • NDC Code(s): 50952-009-09, 50952-009-10, 50952-009-11
  • Packager: pH R&D LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Dimethicone 1%

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  • Purpose

    Skin protectant

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  • Uses

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

    Apply cream liberally as often as needed

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  • Inactive Ingredients

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

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  • Questions?

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

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  • SPL UNCLASSIFIED SECTION

    Distributed by
    pH R&D GinJen
    Hammond, LA 70401

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  • 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
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  • INGREDIENTS AND APPEARANCE
    GOODSTUFF   SKIN PROTECTANT
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50952-009
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone (Dimethicone) Dimethicone 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Mineral Oil  
    Petrolatum  
    Ceresin  
    Sorbitan Sesquioleate  
    Sorbitol  
    Lanolin Alcohols  
    Aluminum Hydroxide  
    Magnesium Hydroxide  
    Butylated Hydroxytoluene  
    Ethylhexylglycerin  
    Phenoxyethanol  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50952-009-09 10 g in 1 PACKET
    2 NDC:50952-009-10 57 g in 1 JAR
    3 NDC:50952-009-11 5 in 1 BOX
    3 50 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 05/26/2013
    Labeler - pH R&D LLC (833115764)
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