Label: AUSANIL - capsicum spp. and ginger spray, metered

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/13

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Capsicum Annuum 3X

    Zingbiger Officianale 3X

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  • Purpose

    Analgesic, Anti-Nausea

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  • Uses

    Rapid temporary symptomatic relief of sever headaches and migraine

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  • Warnings

    For nasal use only.  Keep away from children and animals at all times.  If accidentally swallowed, contact poison control right away.  In case of accidental contact with eyes, flush with water and seek professional help.  Do not use: for a new onset severe or unusual severe headache that is different from your usual pattern of head pain.  Seek medical care immediately.  If you are allergic to the listed ingredients.  If you are pregnant or breast feeding.  Within one hour of using any other nasal spray.  Ask a doctor before use if you have asthma, a deviated nasal septum, frequent nose bleeds or if you have had nasal surgery.  When using this product you may feel a stinging sensation that may last up to several minutes together with watering and reddining of the eyes, flush with water and get medical help.  Stop use and ask a doctor if symptoms persist more than two weeks.

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  • Inactive Ingredients

    Inactive Ingredients: Aloe barbadensis gel, benzalkonium chloride, carboxymethylcellulose and microcrystalline cellulose, capsaicin, citric acid, disodium EDTA, eucalyptol, glycerol, grapefruit seed extract, phenylethylalcohol, polysorbate 80, sodium citrate

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  • Directions

    Directions:

    For use by adults 18 years of age and over Shake bottle well before useRemove cap and safety clip before useHold with thumb at bottom of bottle and nozzle between fingersPrime pump away from your face and eyes before first use and after prolonged non use by depressing several timesSpray once or twice into nostril by completely depressing the nozzleAfter a minute, you may blow your nose to clear itWipe nozzle clean after each useDo not share your spray with others

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  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children and animals at all times. If accidentally swallowed, contact poison control right away.

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  • PREGNANCY OR BREAST FEEDING

    Do not use this product

    If you are pregnant or breast feeding

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  • PRINCIPAL DISPLAY PANEL

    Ausanil 8ml carton

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  • INGREDIENTS AND APPEARANCE
    AUSANIL  
    capsaicin ginger spray, metered
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61324-464
    Route of Administration NASAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSICUM SPP. (CAPSICUM SPP.) CAPSICUM SPP. 3 [hp_X]  in 8 mL
    GINGER (GINGER) GINGER 3 [hp_X]  in 8 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CELLULOSE, MICROCRYSTALLINE  
    GLYCERIN  
    POLYSORBATE 80  
    BENZALKONIUM CHLORIDE  
    CITRIC ACID MONOHYDRATE  
    EUCALYPTOL  
    EDETATE DISODIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61324-464-53 8 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/14/2014
    Labeler - VR1 Corporation (078713613)
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