Label: PROCURE VITAMIN A AND D SKIN PROTECTANT- petrolatum ointment

  • NDC Code(s): 55681-215-02, 55681-215-03, 55681-215-06
  • Packager: TWIN MED, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 8, 2024

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  • Active Ingredients(in each gram)

    White Petrolatum (USP 93.4% w/w)

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Helps seal out wetness
    • Temporarily protects minor cuts, scrapes and burns
    • Temporarily helps protect and helps 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 or minor skin 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

    • Avoid contact with eyes

    Stop use and ask doctor if

    • The condition persists or get worse
    • 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

    • Change wet and soiled diapers promptly
    • Cleanse the diaper area, and allow to dry
    • Apply as needed
  • Other Information

    • Store at room temperature 150 - 300 c ( 590 - 860 F)
    • Avoid excessive heat and humidity
    • Tamper Evident
    • Do not use if packet it torn, cut or opened.
  • Inactive Ingredients

    CI 17240, Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D

  • Principal Display Panel

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    PROCURE VITAMIN A AND D  SKIN PROTECTANT
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM93.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SOLVENT YELLOW 18 (UNII: L4SQI4K87S)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55681-215-03114 g in 1 PACKET; Type 0: Not a Combination Product09/22/2021
    2NDC:55681-215-02144 in 1 BOX09/22/2021
    25 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:55681-215-06425 g in 1 JAR; Type 0: Not a Combination Product09/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/06/2013
    Labeler - TWIN MED, LLC (009579330)
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