Label: BUM EASE- zinc oxide liquid

  • 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 5, 2011

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  • Active Ingredient

    Zinc Oxide 10%

  • 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 eyes.

    Stop use and contact a doctor if:

    • Condition worsens
    • Symptoms last more than seven days or clear up and occur again within a few days.

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

  • Directions

    • Shake Well Before Use
    • Hold bottle 2-3 inches from baby’s bottom while spraying
    • Press down on the pump to spray
    • Change wet and solid diapers promptly
    • Cleanse the diaper area, and allow to dry
    • Apply spray liberally as often as necessary, with each diaper change, especially at
    bedtime or anytime when exposeure to wet diapers may be prolonged

  • Other Information

    • Store at 15° to 25°C (59° to 77°F)

  • Inactive Ingredients

    *Aqua, *Arachis Hypogaea Oil *C14-22 Alcohol, *C12-20 Alkyl, *Coco-Caprylate/Caprate, *Cocoglycerides,
    *Glucoside, *Glycerin, Phenoxyethanol Ethylhexylglycerin, *Oleic Acid and *Silica

    *Natural Ingredients

  • Questions?

    Call toll free 1-800-831-0507

    Distributed by: Wake Innovation, LLC
    P.O. Box 98355 Raleigh, NC
    27624-8355 USA

  • Package Label


    Image of Bottle Label

    Image of Box Label

    Nolan’s Diaper Rash Spray
    Bum Ease ™

    ZINC OXIDE SKIN PROTECTANT DIAPER RASH SPRAY

    NEW ZINC OXIDE SPRAY!!

    Shake well before using

    Patent Pending Spray Formula

    •   Doctor Recommended
    •   Fast / Easy Application
    •   Less Irritation For Baby
    •   Effective Active Ingredients
    •   No Greasy Hands or Fingers

    3.38 fl. oz. (100 ml.)

  • INGREDIENTS AND APPEARANCE
    BUM EASE 
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76330-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    PEANUT OIL (UNII: 5TL50QU0W4)  
    COCONUT ACID (UNII: 40U37V505D)  
    Glycerin (UNII: PDC6A3C0OX)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    C12-20 Alkyl Glucoside (UNII: K67N5Z1RUA)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Oleic Acid (UNII: 2UMI9U37CP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76330-100-101 in 1 BOX
    1100 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/01/2011
    Labeler - Wake Innovation, LLC (967723029)
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