Label: LITTLE ONES PETROLEUM- petrolatum 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 October 30, 2012

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

  • Active Ingredient / Purpose


    White Petrolatum USP (100%) ........................... Skin Protectant
  • Uses


    • Temporarily protects minor: cuts, scrapes, burns
    • Temporarily protects and helps relieve chapped or cracked skin and lips
    • Helps protect from the drying effects of wind and cold weather
  • Keep out of the reach of children

    • Keep out of the reach of children.
  • Use

    • Skin protectant.
  • Warnings

    • When using this product do not get into eyes.
    • See a doctor if condition lasts more than 7 days.
    • Do not use on: deep or puncture wounds, animal bites, serious burns.
    • If swallowed, get medical help, or contact a Poison Control Center right away (1-800-222-1222).

    Directions

    • Apply as needed.
  • PRINCIPAL DISPLAY PANEL

    mm1Petroleum Little Ones Label


  • INGREDIENTS AND APPEARANCE
    LITTLE ONES PETROLEUM 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-945
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-945-03368 g in 1 JAR
    2NDC:49738-945-04212 g in 1 JAR
    3NDC:49738-945-05113 g in 1 JAR
    4NDC:49738-945-0610 g in 1 TUBE
    5NDC:49738-945-07100 g in 1 BOTTLE, PUMP
    6NDC:49738-945-08105 g in 1 JAR
    7NDC:49738-945-09255 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/22/2012
    Labeler - Kmart Corporation (008965873)
    Registrant - Delon Laboratories (1990) Ltd (243387722)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delon Laboratories (1990) Ltd243387722label(49738-945) , manufacture(49738-945) , pack(49738-945)