Label: MURCHISON-HUME WELLNESS WELCOME KIT- alcohol kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 1, 2022

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 75% (v/v)

    Purpose

    Antiseptic

  • Uses

    • To help reduce bacteria on the skin.
  • Warnings

    • For external use only.
    • Do not dispose of wipes in flush toilets.

    Flammable

    • Keep away from fire or flame.

    When using this product

    • avoid contact with eyes.
    • if contact occurs, rinse thoroughly with water.

    Stop using and ask a doctor if

    • irritation or redness develops and lasts.

    Keep out of reach of children

    • In case of accidental ingestion, get medical help or contact a poison control center immediately.
  • Directions

    • Apply to hands or surfaces.
    •  No rinsing required.
    • Discard after use.
  • Other Information

    • Store below 110°F (43°C).
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Aqua (Water), Glycerin. Polyquaternium-37, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 75% (v/v)

    Purpose

    Antiseptic

  • Uses

    To help reduce bacteria on the skin.

  • Warnings

    • For external use only.
    • Flammable. Keep away from fire or flame.

    When using this product

    • avoid contact with eyes.
    • if contact occurs, rinse thoroughly with water.

    Stop using and ask a doctor if

    irritation or redness develops and lasts.

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact a poison control center immediately.

  • Directions

    • Squeeze a significant amount in your palm and rub hands until full dry. No rinsing required.
  • Other Information

    • Store below 110°f (43°C).
  • Inactive ingredients

    Water (Aqua), Glycerin, Acrylates/C-10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aminomethyl Propanol.

  • Kit Label:

    KIT2

  • Package Labeling:69491-303-00

    Label2

  • Package Labeling:69491-301-00

    Label.

  • INGREDIENTS AND APPEARANCE
    MURCHISON-HUME WELLNESS WELCOME KIT 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-305
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69491-305-001 in 1 KIT09/30/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PATCH 5 mL
    Part 21 BOTTLE 20 mL
    Part 1 of 2
    MURCHISON-HUME SANITIZING WIPE WITH TEA TREE OIL 75% ALCOHOL 
    alcohol cloth
    Product Information
    Item Code (Source)NDC:69491-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69491-303-001 in 1 PACKAGE
    15 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/30/2020
    Part 2 of 2
    HAND SANITIZER WITH TEA TREE OIL 75% ALCOHOL 
    alcohol gel
    Product Information
    Item Code (Source)NDC:69491-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69491-301-0020 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/30/2020
    Labeler - Buzz Export Services Pty., Ltd (747317902)
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