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  5. Label Information: Vagical

FDA Label for Vagical

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. KEEP OUT OF THE REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENT
    15. PRINCIPAL DISPLAY PANEL - 10 INSERT BOX

Vagical Product Label

The following document was submitted to the FDA by the labeler of this product Farmina Sp. Z O.o.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Calendula officinalis TINC HPUS*

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


Purpose



Healing agent and anti-inflammatory


Uses



For temporary relief of minor symptoms of vaginitis, such as itching, burning and irritation.


Warnings



For vaginal use only


Do Not Use



  • if you are allergic (hypersensitive) to any of the ingredients found in the insert
  • after expiration date on carton

Ask A Doctor Before Use If You Have



  • strong vaginal discharge
  • vaginal bleeding

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are presently taking other vaginal insert drug products


Otc - When Using



When using this product do not exceed recommended dose.


Stop Use And Ask A Doctor If



  • no improvement is seen after three to four days
  • your symptoms worsen
  • you experience irritation from using the product

Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a health professional before use.


Keep Out Of The Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Adults 18 years and up: Wash hands before and after use. Before use, damp insert with water that has been previously boiled and cooled. Place one insert into vagina 2-3 times per day.
  • Children 12-18 years: Consult a doctor before use.
  • Under 12 years of age: Do not use

Other Information



do not store above 77 degrees F (25 degrees C)


Inactive Ingredient



Polyethylene Glycol.


Principal Display Panel - 10 Insert Box



Vagical®

NDC 68984-001-10

Nature's answer
for vaginal:

* Please review the disclaimer below.