Label: PURISTICS BABY ZINC OXIDE DIAPER RASH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 7, 2011

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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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