Label: ASTONEA XERO- skin protectant 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 December 4, 2022

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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 finalpart34708/18/2022
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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