Label: PREVINC- lemon solution

  • 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 November 16, 2012

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Citrus Limon Burm 1X HPUS

  • PURPOSE

    Purpose

    Cold and Flu Symptom Relief

  • INDICATIONS & USAGE

    Uses   For temporarily relief of cold and flu symptoms

  • WARNINGS

    If pregnant or breast-feeding, ask a health professional before use.

    For nasal use only. To be applied with swabs, do not spray into nasal passages.

    Ask a doctor before use if you:

    •  Have any known allergies to any of the ingredients listed.
    •  Had recent nasal surgery.
    •  Have existing bleeding problems.
    •  Intend to use product on children under 2 years old.
    When using this product     Keep away from eyes, in case of eye contact, immediately flush with water.

    Stop use of this product    if any irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.
  • DOSAGE & ADMINISTRATION

    Directions

    Remove cotton swab from the bag

    • shake the bottle well for 5-7 seconds
    • remove cap and squeeze bottle to apply 3-4 drops to saturate each side of the cotton swab
    • place thumb and index finger at the center of swab tube and apply solution to each nostril using one cotton end per nasal opening (approx. 1/8")
    • after placing just the swab tip in the nose saturate the complete area of each nostril in a circular motion
    • discard swab and secure cap
    • squeeze nostrils to ensure an even distribution of solution
    • PrevinC may be applied every 6-8 hours up to twice daily unless in the presence of a family member with symptoms of cold and flu. No more than 3 applications daily.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Isopropyl Alcohol, Sesame Oil, Aloe Vera Oil Extract

  • STORAGE AND HANDLING

    Other Information      Store in a cool, dry place between 59 degrees F - 84 degrees F (15 degrees C - 29 degrees C)

    • Flammable, keep away from fire
  • QUESTIONS

    Questions or comments

    Call us at 787.993.0655 or visit us online at www.previnc.com

  • SPL UNCLASSIFIED SECTION

    Distributed By: BioHealth Technologies Inc.

    E Street lots 4 and 5 Angora Center,

    Villa Blanca Industrial Park

    Caguas, PR 00725

    United States    Made in USA
  • DESCRIPTION

    PrevinC moisturizes and is a powerful nasal solution that provides up to an 8 hour protective barrier.

    PrevinC is ideal for traveling (e.g., airplanes, busses and trains), when in confined area where air is re-circulated (e.g., offices, schools and hospitals) and when attending crowded public events.

    The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

    Homeopathic

  • DESCRIPTION

    PrevinC

    Homeopathic Nasal Solution

    Citrus Limon Burm

    Say No to Colds!


    Improves your natural protective barriers in the nose!
    For the temporary relief of cold and flu symptoms.

    Ideal when in:
    • Offices
    • Schools
    • Day Cares
    • Hospitals
    • Traveling
    • Events
    Non-Narcotic

    PrevinC improves the natural defense function of the nose, which includes filtration and moisture. Should be applied when in contact with someone with a cold, flu, or when air is recirculated.

    8 Hour Solution

    PrevinC moisturizes and is a powerful nasal solution that provides  up to an 8 hour protective barrier.
    PrevinC is designed for Topical USE ONLY, no warranty, either expressed or inferred is given for usage contrary to the instructions.
    PrevinC may be applied every 6-8 hours up to twice daily unless in the presence of a family member with symptoms of cold and flu. No more than 3 applications daily.

    It is preferred that you blow your nose prior to application if it is stuffy.If you need blow your nose after PrevinC has been applied, then re-apply the solution. Do not exceed 3 applications daily.

    Made with real lemon and aloe
    Homeopathic

    For your protection, this bottle has an imprinted seal around the neck.
    Do not use if tamper evident seal is missing, tampered, broken or destroyed.
  • PRINCIPAL DISPLAY PANEL

    PrevinC

    Homeopathic Nasal Solution

    Citrus Limon Burm

    Say No to Colds!

    8 Hour Solution

    0.17 fl. oz (5ml)

  • PRINCIPAL DISPLAY PANEL

    OuterLabel
  • PRINCIPAL DISPLAY PANEL

    InnerLabel

  • INGREDIENTS AND APPEARANCE
    PREVINC 
    lemon solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28475-810
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEMON (UNII: 24RS0A988O) (LEMON - UNII:24RS0A988O) LEMON1 [hp_X]  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SESAME OIL (UNII: QX10HYY4QV)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28475-810-021 in 1 BOX
    15 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/10/2010
    Labeler - BioHealth Technologies Inc. (788836315)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmalab Enterprises, Inc.174401088manufacture(28475-810)