Label: O24 PAIN NEUTRALIZER- arnica montana liquid
O24 PAIN NEUTRALIZER- arnica montana spray

  • NDC Code(s): 58265-006-30, 58265-007-94
  • Packager: O24 Naturals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 17, 2023

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  • Active ingredient

    Arnica montana 2x HPUS

  • Purpose

    Arnica montana 2x HPUS......................Relieves muscle pain & stiffness, swelling from minor injuries, discloloration from bruises.

    The letters "HPUS" indicate that the active ingredient in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • Uses

    Temporarily relieves muscle pain and stiffness due to:

    • minor injuries
    • overexertion
    • falls

    Reduces symptoms of bruising such as:

    • pain
    • swelling
    • discloloration

    Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

  • Warnings

    For external use only.

    Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.

    When using this product

    • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
    • use only as directed
    • do not tightly wrap or bandage the treated area
    • do not apply heat or ice to the treated area immediately before or after use

    Stop use and ask doctor if

    • condition persists for more than 3 days or worsens
    • symptoms clear up and occur again within a few days

    If pregnant or breastfeeding, consult a health professional before use.

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

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a physician
  • Other information

    store in a cool, dry place

  • Inactive ingredients

    Aloe Barbadensis Leaf juice, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Mentha arvensis Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil

  • Questions or Comments

    Call 1-866-902-8594 or visit www.024zone.com

  • PRINCIPAL DISPLAY PANEL

    O24 Naturals

    O24 Pain Neutralizer

    Homeopathic Topical Temporary Pain Relief

    1 fl oz (30 mL)

    1

    3

    2

  • INGREDIENTS AND APPEARANCE
    O24 PAIN NEUTRALIZER 
    arnica montana liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58265-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA2 [hp_X]  in 9.4 g
    Inactive Ingredients
    Ingredient NameStrength
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58265-007-949.4 g in 1 BOTTLE; Type 0: Not a Combination Product01/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/17/2023
    O24 PAIN NEUTRALIZER 
    arnica montana spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58265-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA2 [hp_X]  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58265-006-301 in 1 CARTON01/17/2023
    130 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/17/2023
    Labeler - O24 Naturals, LLC (962526559)
    Establishment
    NameAddressID/FEIBusiness Operations
    D&D Essential Oils, LLC051894458manufacture(58265-006, 58265-007)
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