Label: OLIVENE DIAPER RASH- zinc oxide ointment

  • 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 June 9, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Zinc Oxide 40%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin 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 lasts more than 7 days.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Change wet and solid diapers promptly
    • Clean the diaper area and allow to dry
    • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged.
  • Other Information

    Store at 20° to 25°C (68° to 77°F)

  • Inactive Ingredients

    Water (Aqua), Mineral Oil, Petrolatum, Beeswax, Lanolin, Olea Europaea (Olive) Oil Unsaponifiables, Oleyl Erucate, Sorbitan Isostearate, DMDM Hydantoin, Glycyrrhetinic Acid, Propylene Glycol, BHT, Ascorbyl Palmitate, Glyceryl Stearate, Citric Acid.

  • Questions or Comments?

    Call 1-888-553-6112 Mon-Fri

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Fischer Pharmaceuticals LTD.
    Bnei Brak 51553, Israel

  • PRINCIPAL DISPLAY PANEL - 113 g. Tube Carton

    MAXIMUM
    STRENGTH

    Dr. Fischer®

    NATURE BABY

    Olivene®
    Diaper Rash Ointment

    Rash Fighting
    40% Zinc Oxide & Soothing
    Olive Oil, Beeswax & Licorice

    Rapid Relief

    113 g. 4 oz.

    FISCHER PHARMACEUTICALS

    Principal Display Panel - 113 g. Tube Carton
  • INGREDIENTS AND APPEARANCE
    OLIVENE   DIAPER RASH
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-413
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Lanolin (UNII: 7EV65EAW6H)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Oleyl Erucate (UNII: 753W099NQ6)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    Enoxolone (UNII: P540XA09DR)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59886-413-991 in 1 CARTON01/11/2013
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34701/11/2013
    Labeler - Fischer Pharmaceuticlas Ltd. (600158976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fischer Pharmaceuticals Ltd.600410514MANUFACTURE(59886-413)
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