Label: BABY DIAPER- zinc oxide cream

  • 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 November 15, 2014

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    ZINC OXIDE, 10%

  • PURPOSE

    PURPOSE

    SKIN PROTECTANT

  • INDICATIONS & USAGE

    USE

    • HELPS TREAT AND PREVENT DIAPER RASH.
    • PROTECTS CHAPPED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS.
  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • WHEN USING

    WHEN USING THIS PRODUCT DO NOT GET INTO EYES.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER 7 DAYS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, SEEK MEDICAL HELP OR CALL POISON CONTROL CENTER IMMEDIATELY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • CHANGE WET AND SOILED DIAPER IMMEDIATELY
    • CLEANSE THE DIAPER AREA AND ALLOW SKIN TO DRY.
    • APPLY OINTMENT LIBERALLY AND AS OFTEN AS NECESSARY WITH EACH DIAPER CHANGE, ESPECIALLY WHEN EXPOSED TO WET DIAPERS FOR A PROLONGED PERIOD OF TIME, SUCH AS BEDTIME.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Ethylhexyl Palmitate, Ricinus Communis (Castor) Seed Oil, Polyglycerin-6 Polyricinoleate, Polyglyceryl-10 Hexaoleate, Glycerin, Dimethicone, Sodium PCA, Ceramide 2, Ceramide 3, Ceramide 6lf, Aloe Barbadensis Leaf Juice, Hyaluronic Acid, Macadamia Ternifolia Seed Oil, Vegetable Oil, Camellia Saliva Seed Oil, Phytostearyl Canola Glycerides, Chamomilla Recutita (Matricaria) Extract, Panthenol (Vitamin B5), Tocopheryl Linoleate, Hydrogenated Coco-Glycerides, Myristyl Myristate, Sorbitan Laurate, Sodium Chloride, Zinc Sulfate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Sodium Benzoate, Potassium Sorbate.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BABY DIAPER 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42643-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    POLYGLYCERIN-6 (UNII: M51422LRAM)  
    POLYGLYCERYL-10 HEXAOLEATE (UNII: 8S25IPV09I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    CORN OIL (UNII: 8470G57WFM)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Coco-Glycerides (UNII: ISE9I7DNUG)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC SULFATE ANHYDROUS (UNII: 0J6Z13X3WO)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42643-101-14100 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2013
    Labeler - TELLURIAN (054233646)
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