PURISTICS BABY ZINC OXIDE DIAPER RASH (ZINC OXIDE) CREAM [SCERENE HEALTHCARE, INC.]

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PURISTICS BABY ZINC OXIDE DIAPER RASH (ZINC OXIDE) CREAM [SCERENE HEALTHCARE, INC.]
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NDC 76026-200-30
Set ID a6cb4d79-3276-a01d-6d5f-ef624cbeb016
Category HUMAN OTC DRUG LABEL
Packager Scerene Healthcare, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active Ingredient

    Zinc oxide 15.0%

  • Purpose

    Diaper rash cream

  • 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

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens

    • symptoms last more than 7 days or clear up and occur again in 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, allow to dry

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

  • Other Information

    • store between 20° to 25°C (68° to 77°F)

    • to open, twist off cap and remove purity seal. Do not use if purity seal is missing or broken.

  • Inactive Ingredients

    beeswax, caprylyl glycol (skin emollient), chamomile extract, citric acid, ethylhexylglycerin (skin emollient), eucalyptus oil/rosewood oil (calming blend of essential oils), glycerin, honeysuckle extract (natural preservative), hydrogenated soybean oil, lecithin (derived from soybeans), panthenol (pro-vitamin B), polylysine (natural preservative), purified water, sodium hyaluronate, sucrose distearate (derived from sugar), sucrose stearate, sunflower seed wax, sweet almond oil

  • Principal Display Panel

    Label

    new!

    the power of pure™

    puristics™

    baby

    ZINC OXIDE

    Diaper Rash Cream

    98% NATURAL

    heals & protects
    no harmful chemicals

    NET WT 3 OZ (85 g)

    discover the power of pure.
    Learn more at www.puristics.com

    ©2010 Distributed by
    Scerene Healthcare, Inc., Peapack, NJ 07977
    1-877-267-0519

    21000210

  • INGREDIENTS AND APPEARANCE
    PURISTICS BABY ZINC OXIDE DIAPER RASH  
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76026-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Chamomile (UNII: FGL3685T2X)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Rosewood Oil (UNII: F2522O5L7B)  
    Glycerin (UNII: PDC6A3C0OX)  
    Lonicera Caprifolium Flower (UNII: 5N1WD9784U)  
    Hydrogenated Soybean Oil (UNII: A2M91M918C)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Panthenol (UNII: WV9CM0O67Z)  
    Water (UNII: 059QF0KO0R)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Sucrose Stearate (UNII: 274KW0O50M)  
    Almond Oil (UNII: 66YXD4DKO9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76026-200-3085 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34712/20/2010
    Labeler - Scerene Healthcare, Inc. (832688209)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioZone Laboratories, Inc555564293MANUFACTURE
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