Label: SELAN PLUS ZINC OXIDE- zinc oxide and dimethicone cream 

  • Label RSS
  • NDC Code(s): 0159-2200-01, 0159-2200-04, 0159-2200-17
  • Packager: PJ Noyes Co. Inc.
  • 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 03/13

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  • Active Ingredients

    Dimethicone 2.1%

    Zinc Oxide 2%

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  • Purpose

    Skin Protectant

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  • Uses

    • Helps treat and prevent diaper rash
    • Protects chaged skin or minor skin irritation due to diaper rash and helps seal out wetness
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  • Warnings

    For external use only

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  • When using this product

    • avoid contact with the eyes
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  • Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
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  • 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 necessary
    • change wet and soiled diapers promptly
    • cleanse the diaper area, and allow to dry
    • apply cream with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
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  • Other Information:

    Store at room temperature

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  • INACTIVE INGREDIENT

    Purified Water USP, Cetyl Alcohol, Sorbitol USP, Glycerol Monostearate, Sodium Lauryl Sulfate, Lanolin USP, Methylparaben, Fragrance, Quaternium-15, Propylparaben.

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  • Image of 4oz tube SelanTUBEimage.jpg
  • Image of 16oz jar
  • Image of 8ml packet
  • INGREDIENTS AND APPEARANCE
    SELAN PLUS ZINC OXIDE 
    selan plus zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0159-2200
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2 g  in 100 g
    DIMETHICONE (DIMETHICONE) DIMETHICONE 2.1   in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CETYL ALCOHOL  
    GLYCERYL MONOSTEARATE  
    LANOLIN  
    SORBITOL  
    SODIUM LAURYL SULFATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    QUATERNIUM-15  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0159-2200-04 117 g in 1 TUBE
    2 NDC:0159-2200-01 8.1 g in 1 PACKET
    3 NDC:0159-2200-17 458 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/29/1997
    Labeler - PJ Noyes Co. Inc. (018927392)
    Establishment
    Name Address ID/FEI Business Operations
    PJ Noyes Co. Inc. 018927392 manufacture(0159-2200), label(0159-2200), pack(0159-2200)
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