MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]

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MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]
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NDC 64768-2922-1
Set ID 163f388e-849d-4b7e-93c1-9045d77a9ec2
Category HUMAN OTC DRUG LABEL
Packager Expanscience Laboratories d/b/a Mustela
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 9.9 %

  • Purpose

    skin protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin and minor irritation associated with diaper rash
    • Helps seal out wetness
  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • conditions worsen
    • symptoms last more than seven days
    • symptoms clear up and occur again within a few days

    Keep out of reach of children.

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

  • Directions

    Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally and as often as necessary and with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

  • Other information

    You may report serious side effects to the phone number provided below or to Expanscience Laboratories Inc. dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022, USA.

    Alumino-plastic tube ensures proper product conservation and facilitates daily use.

  • Inactive ingredients

    BEESWAX, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLOYL GLYCINE, CAPRYLYL GLYCOL, COCO-CAPRYLATE/CAPRATE, ETHYL LINOLEATE, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, LEVULINIC ACID, MAGNESIUM SULFATE, PERSEA GRATISSIMA (AVOCADO) FRUIT EXTRACT, PERSEA GRATISSIMA (AVOCADO) OIL, POLYGLYCERYL-2-DIPOLYHYDROXYSTEARATE, POLYGLYCERYL-3 DIISOSTEARATE, PROPYLENE CARBONATE, SODIUM LEVULINATE, STEARALKONIUM HECTORITE, UNDECYL DIMETHYL OXAZOLINE, WATER

  • Questions or comments ?

    Call toll free 1-800-422-2987 Monday-Friday 9:00am-5:00pm EST

  • Company information

    Distributed in USA by

    Expanscience Laboratories

    dba Mustela, New York, NY 10022, USA

  • PRODUCT PACKAGING - 108 g Tube Carton

    Mustela ®

    FRAGRANCE FREE

    DIAPER RASH CREAM

    Skin Protectant
    with Zinc Oxide

    1
    PREVENTS

    2
    RELIEVES

    3
    RECOVERS

    IRRITATION and REDNESS

    98% INGREDIENTS OF NATURAL ORIGIN

    0% FRAGRANCE

    FROM BIRTH ON
    CLINICALLY TESTED
    HYPOALLERGENIC

    Net Wt. 108g/3.80 OZ

    EXPANSCIENCE ®
    LABORATOIRES

    MUSTELA

  • INGREDIENTS AND APPEARANCE
    MUSTELA DIAPER RASH 1 2 3 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64768-2922
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    AVOCADO (UNII: SDS87L369F)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    4,4-DIMETHYLOXAZOLIDINE (UNII: 96J42P99ZA)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64768-2922-11 in 1 CARTON01/09/2017
    1107.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/09/2017
    Labeler - Expanscience Laboratories d/b/a Mustela (181191057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires Expanscience d/b/a Mustela347941502manufacture(64768-2922)
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