Label: PHARMACYS PRESCRIPTION 4.5 OZ CREAMY PETROLEUM JELLY- white 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 September 17, 2019

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  • Active Ingredient

    Active ingredient:

    Petrolatum 30%

  • Purpose

    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

    Warnings

    For external use only

  • Keep out of reach of children

    Keep out of reach of children:

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Inactive Ingredients

    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.

  • Directions

    Directions apply as needed.

  • INSTRUCTIONS FOR USE

    Do not use on deep puncture wounds, animal bites, serious burns.

  • Stop use and ask a doctor

    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.

  • Indications & Usage

    When using this product do not get into eyes.

  • Pharmacys Prescription 4.5 OZ Creamy Petroleum Jelly

    Creamy Petroleum Jelly

  • INGREDIENTS AND APPEARANCE
    PHARMACYS PRESCRIPTION 4.5 OZ CREAMY PETROLEUM JELLY 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72197-016
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-20 (UNII: 6SU0SC83AH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72197-016-04127.57 g in 1 TUBE; Type 0: Not a Combination Product09/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/17/2019
    Labeler - American Consumer Products Corp (081101181)
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