Label: VITAMIN A AND D- lanolin, petrolatum ointment

  • NDC Code(s): 69396-018-05, 69396-018-40
  • Packager: Trifecta Pharmaceuticals USA LLC
  • 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 May 22, 2023

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  • Active Ingredient

    Lanolin 15.5%

    Petrolatum 53.4%

  • Purpose

    Skin Protectant

  • Uses

    Helps treat and prevent diaper rash

    Protects chafed skin due to diaper rash and helps seal out wetness

  • Stop use and ask a doctor

    Condition worsens

    Symptoms last more than 7 days or clear up and occur again with a few days

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    Change wet and 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.

  • Inactive ingredients

    Cod liver oil (contains Vitamin A and D), fragrance, Mineral Oil, Microcrystalline Wax, Paraffin

  • SPL UNCLASSIFIED SECTION

    Distributed By

    Trifecta Pharmaceuticals USA

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301

    Product of PRC

    www.trifecta-pharma.com

  • Warnings

    For external use only

    When using this product avoid contact with eyes

  • STORAGE AND HANDLING

    Store at controlled room temperature 20º-25ºC (68º-77ºF)

    Questions call 1-888-296-9067

  • Packaging

    vitamin_AD

  • INGREDIENTS AND APPEARANCE
    VITAMIN A AND D 
    lanolin, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15.5 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM53.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-018-051 in 1 BOX01/05/2017
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69396-018-401 in 1 BOX12/19/2019
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/05/2017
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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