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 59º to 86º F (15º to 30º C).

    • Avoid excessive heat and humidity.

  • 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 68599-1186-3

    McKesson

    Skin Protectant Ointment

    With Vitamin A&D

    Temporarily protects chapped or cracked skin

    Net Wt

    4 oz

    (113g)

    MFR# 118-8719

    Not made with natural rubber latex

    Satisfaction Guaranteed

    Distributed by McKesson Medical-Surgical Inc

    Richmond, VA 23233

    Rev. 01 06/16 Made in USA

    8719 each

  • INGREDIENTS AND APPEARANCE
    SKIN PROTECTANT 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-1186
    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
    VITAMIN D (UNII: 9VU1KI44GP)  
    CORN OIL (UNII: 8470G57WFM)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-1186-3113 g in 1 TUBE; Type 0: Not a Combination Product10/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01610/18/201709/01/2024
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(68599-1186)
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