Label: PETROLEUM JELLY- petrolatum cream

  • NDC Code(s): 52000-123-34
  • Packager: Universal Distribution Center LLC
  • 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 November 25, 2021

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  • Drug Facts

  • Active ingredient:

    Petrolatum 30%

  • Purpose

    Skin Protectant

  • Uses

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

  • Warnings

    For external use only.

    When using this product do not get into eyes.

    Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days.

    Do not use on • deep puncture wounds • animal bites • serious burns

    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:

    water (aqua), mineral oil, glycerin, cetearyl alcohol, cetyl alcohol, stearyl alcohol, glyceryl stearate, fragrance, polysorbate 80, laureth-20, BHT, methylparaben, propylparaben, dimethicone, tocopherol.

  • SPL UNCLASSIFIED SECTION

    NEW

    for Dry Skin

    ABSORBS QUICKLY

    Moisturizing

    Replenish Skin Balance

    Compare to the active ingredient of Vaseline® ​Petroleum Jelly Cream*

    ​Helps restore skin's natural moisture

    Distributed by:
    Universal Distribution Center
    96 Distribution Boulevard • Edison, NJ 08817
    www.universaldc.com

    Made in P.R.C

  • Packaging

    Jelly-123

  • INGREDIENTS AND APPEARANCE
    PETROLEUM JELLY 
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    LAURETH-20 (UNII: 6SU0SC83AH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-123-34133 mL in 1 TUBE; Type 0: Not a Combination Product07/27/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/27/2015
    Labeler - Universal Distribution Center LLC (019180459)
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