Label: ASTONEA VITAMIN A AND D- white petrolatum ointment

  • NDC Code(s): 77338-307-02, 77338-307-03, 77338-307-04, 77338-307-05
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • 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 December 10, 2022

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  • Active Ingredient

    White Petroleum Jelly USP (76% 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, espicially at bedtime when exposure to wet diapers may be prolonged

  • 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 in a few days

  • Do not use on

    ■ animal bites ■ deep or puncture wounds ■ serious burns

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

     for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed

  • Other Information

    ■ store at 59-86F (15-30C) ■ avoid excessive heat and humidity

  • Inactive ingredients

    Cholecalciferol, Lanolin, Light Mineral Oil, Microcrystalline Wax, Paraffin, Vitamin A Palmitate

  • Package Label

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA  VITAMIN A AND D
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-307-025 g in 1 PACKET; Type 0: Not a Combination Product05/23/2013
    2NDC:77338-307-0328.3 g in 1 TUBE; Type 0: Not a Combination Product05/23/2013
    3NDC:77338-307-04113 g in 1 TUBE; Type 0: Not a Combination Product05/23/2013
    4NDC:77338-307-05425 g in 1 JAR; Type 0: Not a Combination Product05/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/23/2013
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-307)
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