Vagical Insert
FDA Label NDC 68984-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Farmina Sp. Z O.o. for the product Vagical (NDC 68984-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:

  • ☑itching
  • ☑burning
  • ☑irritation
  • ☑dryness

    • Original French
    Marigold Extract

    10 VAGINAL INSERTS

    Principal Display Panel (10 Insert Box)

    Principal Display Panel (10 Insert Box)

* Please review the disclaimer below.