Label: PURE BABY DIAPER RASH- 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.

Drug Label Information

Updated December 28, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Zinc Oxide 12%

  • 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 cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged.
  • Inactive Ingredients

    Bisabolol, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Coco-Caprylate, Dunaliella Salina Extract, Ethylhexylglycerin, Globularia Alypum Leaf Extract, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Magnesium Sulfate, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Potassium Sorbate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Benzoate, Tocopherol, Water.

  • Questions or Comments?

    Call 1-888-553-6112 Mon-Fri

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Fischer Pharmaceuticals Ltd.
    Tel Aviv, POB 39071, Israel.

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Label

    Dr. Fischer®

    Pure
    baby

    Diaper Rash Cream

    100%
    ORGANIC OILS

    Helps Treat &
    Prevent

    With
    Natural
    Origin Ingredients

    SCIENCE INSIDE
    - SCIENCE INSIDE -

    Hypoallergenic • Sensitive Tested

    NO
    Fragrance, Parabens, SLS, SLES,
    Lanolin, Silicones, Paraffin, GMOs

    Net Wt. 4 oz. (113 g.)

    FISCHER PHARMACEUTICALS

    PRINCIPAL DISPLAY PANEL - 113 g Tube Label
  • INGREDIENTS AND APPEARANCE
    PURE BABY DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-414
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LEVOMENOL (UNII: 24WE03BX2T)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Coco-Caprylate (UNII: 4828G836N6)  
    DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    GLOBULARIA CORDIFOLIA WHOLE (UNII: SD327VQ78H)  
    Glycerin (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polyglyceryl-2 Dipolyhydroxystearate (UNII: 9229XJ4V12)  
    Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Tocopherol (UNII: R0ZB2556P8)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59886-414-32113 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34701/01/2018
    Labeler - Fischer Pharmaceuticals Ltd (600158976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fischer Pharmaceuticals Ltd600410514MANUFACTURE(59886-414)
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