Label: BABYSONS- dexpanthenol ointment

  • NDC Code(s): 73519-001-30
  • Packager: Laboratorios Quimica Son's, S.A. de C.V
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 31, 2024

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  • Drug Facts

  • Active ingredient

    Dexpanthenol 5%

    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 and allow to dry
    • Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Other information

    Keep the tube tightly closed and store at no higher temperature than 86°F / 30°C.

  • Inactive ingredients

    anhydrous lanolin, beeswax, cetyl alcohol, polysorbate 60, polysorbate 80, stearyl alcohol, water, white petrolatum, zinc oxide

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    BABYSONS 
    dexpanthenol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73519-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73519-001-301 in 1 BOX06/15/2020
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/15/2020
    Labeler - Laboratorios Quimica Son's, S.A. de C.V (815603378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Quimica Son's, S.A. de C.V815603378manufacture(73519-001)
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