Label: PHARMACYS PRESCRIPTION CREAMY PETROLEUM COCOA BUTTER- petrolatum jelly

  • NDC Code(s): 76176-122-01
  • Packager: NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.
  • 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 24, 2022

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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, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PHARMACYS PRESCRIPTION CREAMY PETROLEUM COCOA BUTTER 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    LAURETH-20 (UNII: 6SU0SC83AH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-122-01127.57 g in 1 TUBE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2020
    Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)
    Registrant - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.530766098manufacture(76176-122)
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