LANOLIN, PETROLATUM OINTMENT [VI-JON, INC.]

LANOLIN, PETROLATUM OINTMENT [VI-JON, INC.]
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NDC 11344-013-26
Set ID 440b5524-b452-412e-97c1-1ccbac903c29
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART347
  • 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 and 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

    Made in U.S.A. of U.S. and Foreign Parts

    Manufactured by Vi-Jon, Inc.

    St. Louis, MO 63114

    Questions or Comments?  1-888-593-0593

    www.mymountainfalls.com

    *This product is not manufactured or distributed by Shering-Plough Healthcare Products, Inc., distributor of A + D Original Ointment

  • principal display panel

    Mountain Falls Vitamin A&D diaper rash ointment

    skin protectant

    Compare to A+D

    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:11344-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN133 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM459 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:11344-013-261 in 1 CARTON10/03/2017
    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 finalpart34710/03/2017
    Labeler - Vi-Jon, LLC (150931459)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11344-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11344-013)

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