Label: 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 December 12, 2022

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  • Active Ingredient

    White Petrolatum (USP, 100%  w/w)                    

  • Purpose

    Skin Protectant


  • Uses:

    • temporarily protects minor * cuts * scrapes * burns
    • temporarily protects and helps relieve chapped and cracked skin or lips
    • helps protect from the drying effects of wind and cold weather
  • Warnings:

    For external use only.

    Do not use

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • condition lasts more than 7 days or clears up and occurs 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:

    • apply as needed.
  • Inactive Ingredients

    None

  • Other information:

    • Store at 59 Deg F - 86 Deg F (15 - 30 Deg C)
    • Avoid excessive heat.
  • Principal Display Panel

    Petroleum Jelly

    White Petrolatum 100%

    Cardinal Health

    NDC 63517-211-05


    Net Wt 3.25 oz (92.14g)



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  • INGREDIENTS AND APPEARANCE
    PETROLEUM 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63517-211-016 in 1 CASE10/15/2015
    1144 in 1 BOX
    15 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:63517-211-03100 in 1 CASE10/15/2015
    228.3 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:63517-211-05100 in 1 CASE10/15/2015
    392.14 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:63517-211-1024 in 1 CASE10/15/2015
    4284 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/26/2015
    Labeler - Cardinal Health (961027315)
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