Label: FLEXITOL FIRST AID- arnica montana flower and chamomile spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 29, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    *
    The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
    Active ingredientsPurpose
    Arnica Montana (6X H.P.U.S 0.2%)*Healing Agent
    Matricaria Recutita (6X H.P.U.S 0.2%)*Healing Agent
  • Uses

    • Helps promote healing of minor burns, poison ivy, abrasions and skin irritations
    • Relieves sunburn and minor cuts
  • Warnings

    • For External Use Only
    • Avoid contact with eyes, mouth, ears, nose or other sensitive areas. If contact occurs, rinse area thoroughly with water.
    • Keep out of reach of children
    • If pregnant or breast-feeding, ask a health care professional before use.
    • If condition worsens or does not improve after regular use of this product as directed, discontinue use and consult a physician.
  • Directions

    • Rinse wound with warm water
    • Spray onto affected area and absorb excess liquid with a cotton ball
    • Use as required or as directed by a physician
    • For best results use in conjunction with Natralia First Aid Cream
  • Other information

    • Store between 50°- 86°F in a dry place
  • Inactive ingredients

    Aloe Vera Powder, Calendula Officinalis (Calendula) Extract, Carica Papaya (Paw Paw) Extract, Citric Acid, Stellaria Media (Chickweed) Extract, Ethanol, Impatiens Cepenis (Jewelweed), Lavandula Angustifolia (Lavender) Oil, Water

  • Questions or comments?

    Call Toll Free 1-877-687-2542
    usainfo@natralia.com.au
    www.natralia.com.au/usa

  • Principal Display Panel - 2.1 fl oz Label

    NATRALIA
    NATURALLY AUSTRALIAN    ™

    First Aid Spray

    FOR THE RELIEF OF SKIN
    IRRITATIONS & CUTS

    NATURAL HOMEOPATHIC ALTERNATIVE

    Contains 25.1% Ethanol w/w

    Net 2.1 fl oz (60mL) e

    Principal Display Panel - 2.1 fl oz Label
  • INGREDIENTS AND APPEARANCE
    FLEXITOL FIRST AID 
    arnica montana flower and chamomile spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-3353
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER2 mg  in 1 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE2 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43251-3353-71 in 1 CARTON
    160 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other03/12/2010
    Labeler - Laderma Trading Pty Ltd (758651624)
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