BUTTIEZZZ DAILY (ZINC OXIDE) SPRAY [FORTUNIQUE B.V.]

BUTTIEZZZ DAILY (ZINC OXIDE) SPRAY [FORTUNIQUE B.V.]
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NDC 70359-4101-1
Set ID 29b8e3ae-3006-3a96-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Fortunique B.V.
Generic Name
Product Class
Product Number
Application Number PART347
  • Drug Facts

  • Active Ingredients

    Zinc Oxide 4%

  • Purpose

    Skin protectant

  • Uses

    Helps treat and prevent diaper rash

    Helps seal out wetness

  • Warning

    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 7 days or clear up and occur again within a few days

    Not to be applied over deep or puncture wound, infection or lacerations

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Change wet or soiled diapers promptly

    Shake well before use

    Make sure the skin is clean and dry before use.Use a sweeping movement to spray-on the cream in a thin and uniform layer on the buttocks

    Allow to dry

    Use a spraying distance approximately 2 to 3 inches

    Apply Buttiezzz Daily liberally as often as necessary or at every diaper change

  • Other information

    Store at room temperature below 77º F

  • Inactive Ingredients

    Water(Aqua)

    Coco-Caprylate/Caprate

    Glycerin

    Alkyl- Alcohols

    Alkyl Glucoside

    Propylene glycol

    Cocoglycerides

    Caprylyl Glycol

    Capryl-Hidroxamic acid

    Chamomilla Recutita(Matricaria)Flower Extract

    Calendula Officinalis Flower Extract

    Silica

    Oleic Acid

  • Principle Display Panel.50ml Bottle Spray carton

    Butiezzz Daily Carton

  • INGREDIENTS AND APPEARANCE
    BUTTIEZZZ DAILY 
    zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70359-4101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70359-4101-11 in 1 CARTON01/19/2016
    150 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/19/2016
    Labeler - Fortunique B.V. (407788616)
    Registrant - Fortunique B.V. (407788616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fortunique B.V.407788616manufacture(70359-4101)

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