Label: SELAN PLUS ZINC OXIDE 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.

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Updated March 10, 2021

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  • Active Ingredients

    Dimethicone 2.1%

    Zinc Oxide 2%

  • Purpose

    Skin Protectant

  • Uses

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

    For external use only

  • When using this product

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

    • condition worsens or does not improve within 7 days
  • 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 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
  • Other Information:

    Store at room temperature

  • INACTIVE INGREDIENT

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

  • Image of 4oz tube SelanZinc4ozTube.jpg

    Image of 4oz tube artwork

  • Image of 16oz jar SelanZinc16ozJar.jpg

    Image of 16oz Jar Artwork

  • Image of 8ml packet SelanZinc8mlPacket.jpg

    Image of Selan Zinc 8mL Packet Artwork

  • INGREDIENTS AND APPEARANCE
    SELAN PLUS ZINC OXIDE 
    selan plus zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0159-2200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.1   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0159-2200-04117 g in 1 TUBE; Type 0: Not a Combination Product08/29/1997
    2NDC:0159-2200-018.1 g in 1 PACKET; Type 0: Not a Combination Product08/29/1997
    3NDC:0159-2200-17458 g in 1 JAR; Type 0: Not a Combination Product08/29/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/29/1997
    Labeler - Trividia Manufacturing Solutions, Inc (018927392)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trividia Manufacturing Solutions, Inc018927392manufacture(0159-2200) , label(0159-2200) , pack(0159-2200)
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