Label: FRESH BABY SCENT SOOTHING JELLY- petroleum gel

  • 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 February 14, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient: White Petrolatum USP (99.7%)

  • PURPOSE

    Purpose : Skin Protectant

               

  • WARNINGS

    Warnings: For external use only

    Do not use over deep or puncture wounds , infections or lacerations. Ask doctor.


  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children

    In case of accidental ingestion ,seek professional assistance or contact a Poison Control Center right away.


  • INDICATIONS & USAGE


    Directions :
    change wet and solied diapers promply; cleanse diaper area and allow to dry.

    apply product liberally with each diaper change and especially at bedtime or when exposure to wet diapers may be prolonged.





  • DOSAGE & ADMINISTRATION

    Uses: helps treat and prevent diaper rash

               soothes and protects chafed skin due to diaper rash and in wind and cold

               helps seal out wetness


  • INACTIVE INGREDIENT

    Fragrance


  • PRINCIPAL DISPLAY PANEL

    Image of Tube
  • INGREDIENTS AND APPEARANCE
    FRESH BABY SCENT SOOTHING JELLY 
    petroleum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45765-5135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM70.9787 g  in 71 g
    Inactive Ingredients
    Ingredient NameStrength
    JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45765-5135-071 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34701/12/2009
    Labeler - Naterra International INC. (879056786)
    Registrant - Beautymanufacturing Solutions Corperation (783200723)
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