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

  • 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
    • Do not use if tube seal is broken or appears tampered with
    • Always replace cap after use
  • Directions

    • Apply a thin layer of cream and gently massage into affected area
    • Use as required or as directed by a physician
      • For best results use in conjunction with Natralia First Aid Spray
  • Other Information

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

    Aloe Vera Powder, Avocado Oil, Capric/Caprylic Triglycerides, Caprylyl Glycol (and) Sorbic Acid (and) Phenoxyethanol, Carica Papaya (Paw Paw) Extract, Cetearyl Alcohol, Cetyl Palmitate (and) Sorbitan Palmitate (and) Sorbitan Olivate, Stellaria Media (Chickweed) Extract, Theobroma Cacao Butter, Evening Primrose Oil, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Impatiens Cepenis (Jewelweed), Lavandula Angustifolia (Lavender) Oil, Butyrospermum Parkii (Shea Butter), Stearic Acid, Tocopheryl Acetate, Water, Zinc Oxide

  • Questions or Comments?

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

  • Principal Display Panel - 1 oz Carton

    NATRALIA
    NATURALLY AUSTRALIAN    ™

    For the relief of skin irritations such as:

    • Cuts
    • Minor Burns
    • Abrasions
    • Irritation
    • Stings
    • Poison Ivy
    • Minor Rashes
    • Wounds

    Net Wt 1oz (28g) e

    Principal Display Panel - 1 oz Carton
  • INGREDIENTS AND APPEARANCE
    FLEXITOL FIRST AID 
    arnica montana flower and chamomile cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-3363
    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 g
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE2 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43251-3363-81 in 1 CARTON
    128 g in 1 TUBE
    2NDC:43251-3363-90.85 g in 1 POUCH
    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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