Label: WHY DIAPER RASH PADS- zinc oxide cloth

  • 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 January 23, 2015

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  • Active Ingredients:

    Zinc Oxide 20%

  • Purpose:

    Skin Protectant

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Uses:

    Prevents Diaper Rash.
    Soothes & Protects the chafed skin.
    Treats the diaper rash.

  • Warning:

    For external use only.
    Do not use on broken skin.
    Avoid contact with eyes.
    In case of accidental swallowing get medical help or contact poison control immediately.

    Stop usage and consult a doctor:
    Within 3 days if condition does not improve.
    If worsens consult a doctor promptly.

  • Directions:

    Immediately change wet or soiled diapers.
    Clean & allow the diaper area to dry.
    Apply the DIAPER RASH PAD to the affected area & cover with a clean diaper.
    Use it at the first sign of rash or inflammation.
    In order to avoid development of rash may be used before naps or bedtime.

  • Other information:

    Do not use if the packet is open.

  • Inactive ingredients:

    Distilled Water, Glycerin, Olive oil, Spun Lace.

  • QUESTIONS

    Questions: 1-800-281-5609 Mon-Fri: 9am to 5pm PT

    WHY@ESJN.NET

  • SPL UNCLASSIFIED SECTION

    Manufactured/Distributed by:
    Wellness & health for you LLC
    4647 Columbia River Court, San Jose, CA 95136, USA.

  • Packaging

    WHY Diaper pads

  • INGREDIENTS AND APPEARANCE
    WHY DIAPER RASH PADS 
    zinc oxide cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60939-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60939-101-0150 in 1 PACKAGE
    1.70 g in 1 CELLO PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/21/2015
    Labeler - WELLNESS AND HEALTH FOR YOU LLC (079147289)
    Establishment
    NameAddressID/FEIBusiness Operations
    WELLNESS & HEALTH FOR YOU LLC079147289manufacture(60939-101)
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