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
  • 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 September 22, 2021

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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

    DRUG FACT AND PDP

  • 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 finalpart34712/06/2013
    Labeler - TWIN MED, LLC (009579330)
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