Label: ZAXS ORIGINAL BUG BITE AND ITCH- colloidal oatmeal cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 12, 2024

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  • Drug Facts

    Colloidal Oatmeal 5%

  • Active Ingredient

    Colloidal Oatmeal 5%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, poison ivy, oak or sumac, and insect bites.

  • Warnings

    •For external use only.

    •When using this product do not get into eyes or mucous membranes. If this occurs, rinse thoroughly with water.

    •If conditions worsen, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

    •Stop use if:

    •irritation develops.

    •If you are allergic to any ingredient in this product.

    •If hypersensitivity occurs consult a doctor

  • Keep out of the reach of children

    Keep out of the reach of children. If swallowed, consult a Poison Control Centre immediately.

  • Directions

    •Apply as needed.

    •As soon as bug bite itching occurs.

  • Inactive Ingredients

    Alcohol

    Arnica Montana Flower Extract

    Caprylic/Capric Glycerides

    Caprylyl Glycol

    Ceteareth-20

    Cetearyl Alcohol

    Cetyl Alcohol

    Citric Acid

    Cocos Nucifera (Coconut) Oil

    Glycerin

    Glyceryl Stearate

    Glycine Soja (Soybean) Oil

    Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract

    Melaleuca Alternifolia (Tea Tree) Leaf Oil

    Menthol

    Phenoxyethanol

    Sorbic Acid

    Tocopherol

    Water

    Xanthum Gum

  • Other Information

    Store at room temperature.

  • PRINCIPAL DISPLAY PANEL

    Tube Label

  • INGREDIENTS AND APPEARANCE
    ZAXS ORIGINAL BUG BITE AND ITCH 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82186-155
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBIC ACID (UNII: X045WJ989B)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (Off white to yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82186-155-011 in 1 CARTON10/28/2024
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/28/2024
    Labeler - Zax Healthcare Inc. (247378271)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging207062514manufacture(82186-155)
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