Label: SKYLARK- zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL

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 September 8, 2017

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  • Active ingredient

    Zinc Oxide 3.8%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent rash associated with 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 doesn't improve within seven days
  • Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center rightaway

  • Directions

    • Change wet or soiled diapers promptly
    • Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks, lower abdomen and inner thighs
    • Allow area to dry
    • Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged
  • Inactive Ingredients

    Aloe Barbadensis Gel, Chloroxylenol, Cholecalciferol (Vitamin D3), Zea Mays Oil, Fragrance, Lanolin, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate (Vitamin A), Sodium Borate, Tocopherol Acetate (Vitamin E), Water, White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    Front PanelDrug Fact Panel

  • INGREDIENTS AND APPEARANCE
    SKYLARK 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71168-8020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CORN OIL (UNII: 8470G57WFM)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71168-8020-0100 g in 1 TUBE; Type 0: Not a Combination Product08/01/2017
    2NDC:71168-8020-4452 g in 1 JAR; Type 0: Not a Combination Product08/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2017
    Labeler - Skylark CMC (650174824)