Label: BABY FRESH SCENT PETROLEUM- white petroleum jelly

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 26, 2012

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

  • Active ingredient

    White petrolatum USP (99.9 %)

  • Purpose

    Skin protectant

  • Uses

    • Ideal for your baby’s skin care needs

    • Restores smooth and healthy skin

    • Helps to treat and prevent your baby’s delicate skin from diaper rash

    • It works to seal out wetness

    • Helps to soothe dry, chapped, cracked or irritated skin and lips due to cold and wind

  • Warnings

    For external use only.

  • Do not use

    over deep or puncture wounds, infections or lacerations. Ask a doctor.

  • When using this product

    avoid contact with eyes.

  • Stop use and ask a doctor

    if condition worsens or does not improve after 7 days.

  • Keep out of reach of children

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

  • Directions

    Cleanse and dry area, apply liberally, as often as necessary.

  • Inactive ingredients

    Fragrance

  • PRINCIPAL DISPLAY PANEL

    BABY FRESH SCENT

    PETROLEUM JELLY

    SKIN PROTECTANT FOR BABIES

    NET WT. 8 OZ (226 g)

    PRINCIPAL DISPLAY PANEL



  • INGREDIENTS AND APPEARANCE
    BABY FRESH SCENT PETROLEUM 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50346-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.99 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50346-002-01100 g in 1 JAR
    2NDC:50346-002-02113 g in 1 JAR
    3NDC:50346-002-03142 g in 1 JAR
    4NDC:50346-002-04170 g in 1 JAR
    5NDC:50346-002-05198 g in 1 JAR
    6NDC:50346-002-06226 g in 1 JAR
    7NDC:50346-002-07255 g in 1 JAR
    8NDC:50346-002-08283 g in 1 JAR
    9NDC:50346-002-09368 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/26/2012
    Labeler - Pan Aromas LLC (078451131)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture