Label: ASTONEA XERO- skin protectant ointment

  • NDC Code(s): 77338-022-23
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 25, 2024

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  • ​Active Ingredients:

    Zinc Oxide 15%

    Dimethicone 1%

  • Purpose:

    Skin Protectant

  • Uses:

    • Helps treat and prevent diaper rash.
    • Protects minor skin irritation associated with

    diaper rash and helps seal out wetness.

  • ​Warnings:

    • For external use only,
    • Avoid contact with eyes, In case of contact, flush thoroughly with water.
  • Warnings:

    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.

  • Warnings:

    Keep out of reach of children.

    In case of accidental ingestion contact a physician or Poison Control Center right away.

  • Directions:

    • Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry.
    • Apply cream 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 15-30 °C
  • Inactive Ingredients:

    Aloe vera Extract, Cholecalciferol, Eugenia Caryophyllus Flower Oil, Lanolin, Light Liquid Paraffin, Petrolatum, Retinyl Palmitate,Tocopheryl Acetate

  • Label Principal Display Panel

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA XERO 
    skin protectant ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    LANOLIN (UNII: 7EV65EAW6H)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-022-23113 g in 1 TUBE; Type 0: Not a Combination Product08/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/18/2022
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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