Label: GOODSENSE DIAPER RASH- zinc oxide paste

  • Category: HUMAN OTC DRUG LABEL

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 5, 2016

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  • ACTIVE INGREDIENT

    Active ingredient                                                                   Purpose

    Zinc oxide 40%......................................................... Skin protectant

  • PURPOSE

    Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • do not get into eyes
  • STOP USE

    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

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    Directions

    • change wet and soiled diapers promptly
    • cleanse the diaper area
    • allow to dry
    • apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • STORAGE AND HANDLING

    Other information

    • store at 20° to 25°C (68° to 77°F)
    • Lot No. & Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients butylhydroxyanisole, lavender oil, liquid paraffin, methylparaben, petrolatum, polysorbate 60, purified lanolin, sorbitan monostearate, squalane, talc, tocopherol, acetate, water

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Geiss, Destin & Dunn, Inc.

    Peachtree City, GA 30269

    www.valuelabels.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    GOODSENSE DIAPER RASH 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-779
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SQUALANE (UNII: GW89575KF9)  
    TALC (UNII: 7SEV7J4R1U)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-779-041 in 1 BOX
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/05/2016
    Labeler - Geiss, Destin & Dunn, Inc. (076059836)
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