Label: BODY CARE GIFT SET- zinc oxide kit

  • 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 February 18, 2016

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  • Active Ingredients

    Zinc Oxide: 19%

  • Purpose

    Skin Protectant

  • Uses

    * Helps treat and prevent diaper rash
    * Protects chafed skin associated with diaper rash
    * Helps protect against wetness

  • Warnings

    For external use only.

    When using this product * avoid contact with eyes.

    Stop use and ask a doctor if * condition worsens * symptoms last more than 7 days or clear up and return again within a few days.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    * Change wet or soiled diaper 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 exposure to wet diapers may be prolonged.

  • Inactive Ingredients

    Helianthus Annuus (Sunflower) Seed Oil (1), Beeswax (1), Glyceryl Dibehenate, Tribehenin, Aloe Barbadensis Leaf Juice (1), Glyceryl Behenate, Tocopheryl Acetate, Carthamus Tinctorius (Safflower) Seed Oil (1), Olea Europae (Olive) Fruite Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Calendula Officialis Flower Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1)(1) Certified Organic Ingredient

  • Questions?

    Questions? Visit giggle.com or call 800-495-8577

  • PRINCIPAL DISPLAY PANEL

    Body Care Gift Set

  • INGREDIENTS AND APPEARANCE
    BODY CARE GIFT SET 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70306-9804
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70306-9804-91 in 1 KIT03/01/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 355 mL
    Part 21 JAR 85 g
    Part 31 TUBE 118 mL
    Part 1 of 3
    FACE AND BODY LOTION 
    lotions, oils, powders, and creams lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRGLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRCASTOR OIL (UNII: D5340Y2I9G)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGRCHAMOMILE (UNII: FGL3685T2X)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
    INGRANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    INGRCARNAUBA WAX (UNII: R12CBM0EIZ)  
    INGRHYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    colorwhiteC48325
    flavorVANILLAC73421
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/01/2016
    Part 2 of 3
    ALL-PURPOSE WONDER BALM 
    other baby products ointment
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCASTOR OIL (UNII: D5340Y2I9G)  
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
    INGRHYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    INGRALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    colorwhiteC48325
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    185 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/01/2016
    Part 3 of 3
    DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Item Code (Source)NDC:70306-1851
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    JOJOBA OIL (UNII: 724GKU717M)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    Product Characteristics
    Colorwhite (Off-White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70306-1851-4118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2016
    Labeler - giggle (194045402)
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