Label: SMARTCHOICES LANOLIN PLUS 0- lanolin 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 October 23, 2015

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  • Directions

    Apply 0.15g once a day.

    Smooth onto nipple area as needed

  • For external use

    For external use

  • Inactive Ingredient

    Caprylic capric triglyceride 50%

  • USEAGE

    Helps prevent and treat sore nipples due to breast feeding

  • Purpose

    Helps prevent and treat sore nipples due to breast feeding

  • Warning

    Keep out of reach of children

  • Active Ingredient

    Lanolin usp 50%

  • Ultra pure Lanolin

    Reverse of packagingKamolan, Lanolin (ultra pure pharmacetical grade, USP modified Lanolin) Caprylic Capric Triglyceride (fractioned coconut oil)

  • PRINCIPAL DISPLAY PANEL

    Front of packaging

  • INGREDIENTS AND APPEARANCE
    SMARTCHOICES LANOLIN PLUS  0
    lanolin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70196-1333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN1 mg  in 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70196-1333-22 mg in 1 PACKET; Type 0: Not a Combination Product10/10/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2010
    Labeler - Florri Feme Pharmaceuticals Ltd (213924185)
    Registrant - Florri Feme Pharmaceuticals Ltd (213924185)
    Establishment
    NameAddressID/FEIBusiness Operations
    Florri Feme Pharmaceuticals Ltd213924185manufacture(70196-1333)
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Safety

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Related Resources

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