Label: DRXNOZE NOSEBLEED RELIEF- achillea millefolium, marrubium vulgare, stachys betonica, urtica dioica swab

  • 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 31, 2014

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

  • Active ingredients

    Achillea millefolium 1X, Marrubium vulgare 1X, Stachys betonica 1X, Urtica dioica 1X

  • Purpose

    Astringent

  • Keep Out of Reach of Children

    Keep out of the reach of children.

  • Uses

    Shortens duration of minor nose bleeds.

  • Warnings

    For Nasal Passage Use Only. Do not use if you are allergic to any ingredient in this product.

    When using this product

    Avoid contact with eyes.
    Do not use for deep or puncture wounds, animal bites, or serious burns.
    In case of accidental contact with eyes, flush with water and immediately seek professional help.
    Keep out of the reach of children.
    Each applicator is designed for one person, single use.
    If pregnant or breastfeeding, ask a health professional before use.
    Consult a physician if bleeding persists for longer than 30 minutes.
    Consult a physician if symptoms persist for more than 7 days or worsen.
    Do not use if seal is broken.
    Children under 6 years of age: consult a physician before use.
    In case of overdose, get medical help or contact a Poison Control Center immediately.
  • Directions

    Adults and children 6 years and older:
    1. Peel back tab on package to expose swab.
    2. Remove swab from package.
    3. Blow nose gently to remove excess blood from nasal passage.
    4. Apply swab to affected area in nasal passage.
    5. Pinch nostril with swab in place (tilt chin slightly downward).
    6. Keep swab in place for 1 minute.
    7. Remove swab and gently blow out excess blood from nostril.
    8. If bleeding persists, twist swab ½ turn and reinsert for 1-2 minutes or until bleeding stops.
    9. Dispose of swab after use.

  • Inactive Ingredients

    aloe vera, citric acid, glycerin, hydroxyethyl-cellulose, polysorbate 20, potassium sorbate, purified water, sodium benzoate, sodium chloride

  • Other Information

    Store at 68-77°F (20-25°C)

  • Package/Label Principal Display Panel

    DRxNOZE® NOSEBLEED RELIEF

    Works Fast! Natural Active Ingredients!

    Helps natural blood clotting
    Easy to use, works quickly
    No stinging
    Effective stopping rebleeds
    No strips to clog nostrils
    Pharmacist developed

    Contains 5 Nasal Swabs (1 swab per dose)

    Homeopathic

    Manufactured and distributed for:

    ByzMed, LLC

    Cottage Grove, WI 53527 USA

    www.DrxNoze.com

    Made in the USA

    US Patent 8,414,935

    Foreign application pending

    ©2013 Byzmed, LLC

    Questions or comments? Call (866-473-1740) or email us at: customerservice@DrxNoze.com.

    Visit us at www.DrxNoze.com

    These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

    Carton Front

    Carton Label – Front

    Carton Label - Back
     
    Carton Label – Back
  • INGREDIENTS AND APPEARANCE
    DRXNOZE NOSEBLEED RELIEF 
    achillea millefolium, marrubium vulgare, stachys betonica, urtica dioica swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58092-001
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM1 [hp_X]  in 1.5 mL
    MARRUBIUM VULGARE (UNII: 7A72MUN24Z) (MARRUBIUM VULGARE - UNII:7A72MUN24Z) MARRUBIUM VULGARE1 [hp_X]  in 1.5 mL
    STACHYS OFFICINALIS (UNII: UO9989Y17N) (STACHYS OFFICINALIS - UNII:UO9989Y17N) STACHYS OFFICINALIS1 [hp_X]  in 1.5 mL
    URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA1 [hp_X]  in 1.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58092-001-015 in 1 CARTON
    11.5 mL in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic02/01/2014
    Labeler - ByzMed, LLC (828557921)
    Registrant - Oasis Health Products, Inc. (964858315)