Vagical: Homeopathic Product Information

VAGICAL — calendula officinalis flowering top insert
Farmina sp. z o.o.

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.

Vagical

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

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

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

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
(click image for full-size original)
VAGICAL
calendula officinalis flowering top insert
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68984-001
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 150 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68984-001-10 10 INSERT in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 05/29/2014
Labeler — Farmina sp. z o.o. (422254391)
Establishment
Name Address ID/FEI Operations
Farmina sp. z o.o. 422254391 manufacture (68984-001)

Revised: 01/2023 Farmina sp. z o.o.

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