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: OTC monograph not 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, 2020

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

  • 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
    OTC monograph not finalpart34706/15/2020
    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)