Vagical

Vagical
SPL v7
SPL
SPL Set ID 0ab35c03-942e-4ba5-ba5a-65c5a99830d7
Route
VAGINAL
Published
Effective Date 2023-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (150 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-05-29
Description

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

Medication Information

Purpose

Healing agent and anti-inflammatory

Description

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.

Uses

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

Section 50567-7

When using this productdo not exceed recommended dose.

Section 50568-5

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

Section 53414-9

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

Warnings

For vaginal use only

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

Do Not Use
  • if you are allergic (hypersensitive) to any of the ingredients found in the insert
  • after expiration date on carton

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.

Other Information

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

Inactive Ingredient

Polyethylene Glycol.

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

Keep Out of the Reach of Children.

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

Ask A Doctor Before Use If You Have
  • strong vaginal discharge
  • vaginal bleeding

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

Structured Label Content

Uses

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

Section 50567-7 (50567-7)

When using this productdo not exceed recommended dose.

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

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

Purpose

Healing agent and anti-inflammatory

Warnings

For vaginal use only

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

Do Not Use (Do not use)
  • if you are allergic (hypersensitive) to any of the ingredients found in the insert
  • after expiration date on carton

Active Ingredient (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.

Other Information (Other information)

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

Inactive Ingredient (Inactive ingredient)

Polyethylene Glycol.

Stop Use and Ask A Doctor If (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

Keep Out of the Reach of Children. (Keep out of the reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • strong vaginal discharge
  • vaginal bleeding

Principal Display Panel 10 Insert Box (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:56.954132 · Updated: 2026-03-14T23:17:15.281880