Label: LANOLIN, 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 17, 2023

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  • Active ingredients

    Lanolin 15.5%

    Petrolatum 53.4%

  • Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • temporarily protects minor: -cuts - scrapes - burns
    • temporarily protects and helps relieve chafed, chapped or cracked skin and lips
    • helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

  • When using this product

    • do not get into eyes
  • 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
  • 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 skin protectant use: apply as needed
    • for diaper rash use:
    • change wet or soiled diapers promptly
    • cleanse the diaper area 
    • allow to dry
    • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • other information

    store between 20º and 25ºC (68º and 77º F)

  • Inactive ingredients

    cod liver oil (contains vitamins A+D), fragrance, light mineral oil, microcrystalline wax, paraffin

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of A+D® Original Ointment

    Distributed by: Vi-Jon, LLC,

    St. Louis, MO 63114

  • principal display panel

    Swan

    VITAMIN A&D OINTMENR

    Diaper Rash Ointment & Skin Protectant 

    protects & soothes

    Helps heal dry, chafed skin

    Prevents and treats diaper rash

    Seals out wetness

    Dermatologist tested

    Hypoallergenic

    *Compare to A+D Original Ointment*

    NET WT 4 OZ (113 g)

    image description

  • INGREDIENTS AND APPEARANCE
    LANOLIN, PETROLATUM 
    lanolin, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN155 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM534 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0107-261 in 1 CARTON12/30/2020
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/30/2020
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0869-0107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0869-0107)
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