Label: PETROLEUM- white petrolatum jelly

  • NDC Code(s): 53329-068-01, 53329-068-04, 53329-068-16, 53329-068-44, view more
    53329-068-96
  • Packager: Medline Industries, LP
  • 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 August 8, 2023

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  • Active ingredient (in each gram)

    Petrolatum 100%

  • Purpose

    Skin Protectant

  • Uses

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

    • For external use only

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last for 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

    apply as needed.

  • Other information

    • Store at controlled room temperature 68º-77ºF (20º-25ºC).
    • Use only if packaging is intact.
  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA of Domestic and Imported Materials

    www.curad.com

    1-800-633-5463

    REF: CUR005331

    V1 RD22SFZ

  • Inactive ingredients

    N/A

  • Package Label

    Label V1 RD22SFZ

  • INGREDIENTS AND APPEARANCE
    PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-068-96144 in 1 CARTON01/01/2018
    1NDC:53329-068-165 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:53329-068-011 in 1 BOX01/01/2018
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:53329-068-44113 g in 1 TUBE; Type 0: Not a Combination Product01/01/201801/01/2022
    4NDC:53329-068-04118.29 g in 1 TUBE; Type 0: Not a Combination Product02/21/201901/01/2022
    5NDC:53329-068-165 g in 1 PACKET; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01601/01/2018
    Labeler - Medline Industries, LP (025460908)
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