Label: SKIN PROTECTANT- petrolatum ointment

  • 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 January 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each gram)

    White Petrolatum 93.5%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

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

    Warnings For external use only.
    When using this product

    • do not get into eyes
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • a rash or allergic reaction develops
    • symptoms last more than 7 days or clear up and occur again within a few days
  • DO NOT USE

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed.

  • OTHER SAFETY INFORMATION

    Other information

    • Store at controlled room temperature 59-86ºF (15-30ºC).
    • Avoid excessive heat and humidity.
    • Tamper Evident. Do not use if packet is torn, cut or opened.
  • INACTIVE INGREDIENT

    Inactive ingredients Corn Oil, Light Mineral Oil, Vitamin A Palmitate, Vitamin D

  • QUESTIONS

    Questions? Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-1187-5
    McKesson
    Skin Protectant
    Ointment
    WITH VITAMINS A & D
    Temporarily protects chapped or cracked skin.
    MFR # 118-8744
    NET WT
    5 g
    (0.18 OZ)
    144 PER BOX

    8744 box

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-1187-5
    McKesson
    Skin Protectant
    Ointment
    WITH VITAMINS A & D
    Temporarily protects chapped or cracked skin.
    MFR # 118-8744
    NET WT
    5 g
    (0.18 OZ)
    8744 each

  • INGREDIENTS AND APPEARANCE
    SKIN PROTECTANT 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-1187
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM93.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-1187-55 g in 1 BOX; Type 0: Not a Combination Product10/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01610/19/201705/01/2025
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(68599-1187)
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