Label: ASTONEA SKIN PROTECTANT- zinc oxide 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 August 8, 2022

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  • Drug Facts

  • Active ingredient

    Zinc Oxide (1.8% w/w)

    Purpose

    Skin Protectant

  • Uses:

    • Helps treat and prevent diaper rash, incontinence or exposure to feces and urine
    • Protects Skin against irritation due to such rash and
    • Helps protect skin from exposure to wetness
  • Warnings:

    For external use only

    When using this product

    • Avoid contact with eyes
    • If eye contact occurs, flush with water

    Stop use and ask a doctor if:

    • Condition worsens or does not improve within seven days

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away
  • Directions:

    • Change wet or solied diapers promptly
    • Clean diaper area with a mild cleanser, paying special attention to the perinium, buttocks, lower abdomen and inner thighs
    • Allow to dry
    • Apply to affected area as often as necessary or with each diaper change, especially at bedtime or any time when exposure to soiled diapers may be prolonged
  • Other information:

    • Store at room temperature 15º - 30ºC (59º - 86ºF)
    • Avoid excessive heat
  • Inactive ingredients:

    Aloe Barbadensis Gel, Alpha-Tocopherol(Vitamin E), Cetostearyl Alcohol, Cholecalciferol (Vitamin D), Ethylhexylglycerine, FD&C Yellow No. 5, FD&C Yellow No. 6, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Lavender, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Benzoate, Sodium Laureth-3 Sulfate, stearic acid, Vitamin A Palmitate, Water.

  • Package Labeling:

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA SKIN PROTECTANT 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-050-04113 g in 1 TUBE; Type 0: Not a Combination Product08/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/21/2019
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-050)
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