AUSANIL - capsaicin ginger spray, metered 
VR1 Corporation

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 Facts

Active Ingredients

Capsicum Annuum 3X

Zingbiger Officianale 3X

Purpose

Analgesic, Anti-Nausea

Uses

Rapid temporary symptomatic relief of sever headaches and migraine

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.

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

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

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

Do not use this product

If you are pregnant or breast feeding

Ausanil 8ml carton

Ausanil 8ml carton

AUSANIL  
capsaicin ginger spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61324-464
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM SPP. (UNII: T5KDM4J239) (CAPSICUM SPP. - UNII:T5KDM4J239) CAPSICUM SPP.3 [hp_X]  in 8 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER3 [hp_X]  in 8 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EUCALYPTOL (UNII: RV6J6604TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61324-464-538 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/14/201406/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/14/201406/05/2017
Labeler - VR1 Corporation (078713613)

Revised: 12/2018
 
VR1 Corporation