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

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    Warning

    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 that 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 righ 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.
  • 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 68599-1185-7

    McKesson

    Skin Protectant Ointment

    With Vitamins A&D

    Temporarily protects chapped or cracked skin

    Net Wt.

    13 oz

    (368.5g)

    MFR#188-8712

    Not made with natural rubber latex

    Satisfaction Guaranteed

    Distributed by McKesson Medical-Surgical Inc.

    Richmond, VA 23233 Rev. 02 06/16 Made in USA

    8712 each

  • INGREDIENTS AND APPEARANCE
    SKIN PROTECTANT 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-1185
    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
    CORN OIL (UNII: 8470G57WFM)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-1185-7368.5 g in 1 JAR; Type 0: Not a Combination Product10/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01610/18/201703/01/2025
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(68599-1185)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!