Label: GERIGENTLE-VITAMINS A AND D- 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 November 10, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    White Petrolatum USP (93%w/w)

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Helps seal out wetness
    • Temporarily protects minor
      • cuts
      • scrapes
      • burns
    • Temporarily helps protect and 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 wetness may be prolonged
  • Warnings

    For external use only

    When using this product

    • Do not get into eyes

    Stop Use and consult a doctor if

    • condition worsens
    • symptoms last more than 7 days
    • symptoms clear up and reoccur in a few days

    Do not use on

    • deep puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children! If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions for use with Diaper Rash

    • change wet and soiled diaper promptly
    • cleanse the diaper area and allow to dry
    • apply as needed
  • Other information

    • store at 15°-30°C (59°-86°F)
    • avoid excessive heat and humidity
  • Inactive Ingredients

    • Lanolin, Lavender Oil, Light Liquid Paraffin, Vitamin A and Vitamin D
  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

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  • INGREDIENTS AND APPEARANCE
    GERIGENTLE-VITAMINS A AND D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73235-1053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.93 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73235-1053-312 in 1 CARTON01/15/2015
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:73235-1053-25 g in 1 PACKET; Type 0: Not a Combination Product01/15/2015
    3NDC:73235-1053-4144 in 1 BOX03/16/2020
    35 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/15/2015
    Labeler - AG INTERNATIONAL (675480459)
    Establishment
    NameAddressID/FEIBusiness Operations
    AG INTERNATIONAL675480459manufacture(73235-1053)
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