Label: DR. SELBY DIAPER RASH- zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 23, 2024

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  • Drug Facts

  • Active ingredient

    Zinc Oxide 6.5%

    Purpose

     Skin Protectant

  • Use

    • 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 Poison Control Center right away.

  • Directions

    • Change wet and soiled diapers promptly.
    • Cleanse the diaper area and allow to dry.
    • Apply ointment liberally as ofter as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Other information

    store at 59° - 86°F (15°-30°C)

  • Inactive ingredients

    boric acid, lanolin, light mineral oil, petrolatum, talc, vitamin D, water

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    DR. SELBY DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47143-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION65 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TALC (UNII: 7SEV7J4R1U)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47143-003-4040 g in 1 TUBE; Type 0: Not a Combination Product03/21/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/21/2014
    Labeler - Terry S.A. (966079147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Terry S.A.966079147manufacture(47143-003)