Label: ASTONEA A AND D WITH LANOLIN- lanolin, petrolatum ointment

  • NDC Code(s): 77338-213-04
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 5, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Lanolin 15.5%Skin Protectant
    Petrolatum 53.4%Skin Protectant
  • Uses

    • helps treat and prevent diaper rash
    • temporarily protects minor:
      • cuts
      • scrapes
      • burns
    • temporarily protects and helps relieve chapped, chafed or cracked skin and lips
    • protect chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only

    Do not use on

    • deep or puncture wounds .
    • animal bites
    • serious burns .

    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 within a few days

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • for skin protectant useapply as needed
    • for diaper rash use:
      • 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
  • Other information

    • store between 20°C to 25 °C ( 68° to 77°F)
    • do not use if tube seal under cap is broken
  • Inactive Ingredients

    cholecalciferol, light mineral oil, microcrystalline wax, paraffin, vitamin A palmitate

  • TheraCare A&D Ointment

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA A AND D WITH LANOLIN 
    lanolin, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-213
    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
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-213-041 in 1 CARTON09/01/2021
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/01/2021
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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