Label: LINCOLN- white 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 10, 2017

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  • ACTIVE INGREDIENT

    White Petrolatum USP (76% w/w)

  • PURPOSE

    Skin Protectant

  • USES

    • helps treat and prevent diaper rash
    • helps seal out wetness
    • temporarily protects minor cuts, scrapes, burns
    • temporarily helps protect and relieve chapped and cracked skin or lips
    • helps prevent and protect from the drying effects of wind and cold weather
    • helps prevent and protect chafed skin in minor irritations associated with diaper rash
    • with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged
  • WARNINGS:

    FOR EXTERNAL USE ONLY

  • When using this product:

    • do not get into eyes
  • Stop Use and ask a doctor if

    • conditions worsens
    • symptoms last more than 7 days or clear up and occur again in a few days
  • Do not use on

    • deep or 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

    For Diaper Rash:

    change wet and soiled diaper promptly
    cleanse the diaper area allow to dry
    apply as needed

  • OTHER INFORMATION

    • store at room temperature 15° - 30 °C (59-86 F)
    • avoid excessive heat and humidity
  • INACTIVE INGREDIENTS

    lanolin, lavender oil, light liquid paraffin, vitamin A, Vitamin D

  • PRINCIPAL DISPLAY PANEL

    Principal Display and Drug Fact Label

  • INGREDIENTS AND APPEARANCE
    LINCOLN 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69636-3045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69636-3045-25 g in 1 PACKET; Type 0: Not a Combination Product01/10/2017
    2NDC:69636-3045-328.3 g in 1 TUBE; Type 0: Not a Combination Product01/10/2017
    3NDC:69636-3045-4113 g in 1 TUBE; Type 0: Not a Combination Product01/10/2017
    4NDC:69636-3045-5425 g in 1 JAR; Type 0: Not a Combination Product01/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/10/2017
    Labeler - Lincoln Pharmaceuticals Ltd. (915839373)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lincoln Pharmaceuticals Ltd.915839373manufacture(69636-3045)
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