Label: SHOPKO DIAPER RASH MAXIMUM STRENGTH- zinc oxide cream

  • 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 December 3, 2013

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Zinc Oxide........40.0%

  • Purpose

    Skin Protectant

  • 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 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
    • allow to dry
    • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
  • Other Information

    • store at 20º to 25ºC (68º to 77ºF)
  • Inactive ingredients

    cod liver oil, talc, petrolatum, lanolin, water, methylparaben, fragrance, BHA

  • Package/Label Principal Display Panel

    SHOPKO®

    Diaper Rash Paste Maximum Strength

    40% Zinc Oxide

    Helps Heal, Soothe & Prevent Diaper Rash

    Compare to Desitin® Maximum Strength Original Paste 40% Zinc Oxide Diaper Rash Paste Ingredients

    NET WT 4 OZ (113 g)

    SHOPKO® Diaper Rash Paste Maximum Strength provides overnight relief for your baby's delicate skin. This rich, dermatologist-tested and hypoallergenic formula contains the maximum level of zinc oxide to instantly form a protective barrier to help heal and soothe discomfort caused by diaper rash.

    *This product is not manufactured or distributed by Johnson & Johnson® Consumer Products Company, owner of the registered trademark Desitin®

    Distributed by Emilia Personal Care Inc.
    5890 Sawmill Road, Suite 230, Dublin, OH 43017
    Questions? Call 1-866-543-5125
    Made in Israel
    SHOPKO® Satisfaction Guaranteed
    By Refund or Exchange
    ©2013 ShopKo Stores Operating Co., LLC
    0D927 8C C1

    SHOPKO Diaper Rash Paste Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    SHOPKO DIAPER RASH MAXIMUM STRENGTH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-927
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    TALC (UNII: 7SEV7J4R1U)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-927-111 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/10/2013
    Labeler - Shopko Stores Operating Co., LLC (023252638)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!