Yeastcalm

Yeastcalm
SPL v3
SPL
SPL Set ID cd384b93-b803-8810-e053-2a95a90acdf0
Route
VAGINAL
Published
Effective Date 2026-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Goldenseal (5 [hp_X]) Calendula Officinalis Flowering Top (1 [hp_X]) Borate Ion (14 [hp_X]) Candida Albicans (30 [hp_X])
Inactive Ingredients
Water Gelatin Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-10-01

Description

Active Ingredients** (in each suppository) Borax 14X HPUS (0.15 g) Calendula officinalis 1X HPUS (0.15 g) Candida albicans 30X HPUS (0.15 g) Hydrastis canadensis 5X HPUS (0.15 g) (contains less than 10 -3 hydrastine and berberine alkaloids) The letters "HPUS" indicate that the components in the product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Warnings and Precautions

For vaginal use only. This product will not cure a yeast infection.

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

YeastCalm vaginal suppository may damage condoms and diaphragms and cause them to fail.

Indications and Usage

Uses*

  • if this is the first time you have vaginal itching and discomfort, see your doctor to find out if you have a vaginal yeast infection
  • temporarily relieves symptoms of vaginal yeast infection (candidiasis) such as:

  • minor vaginal itching
  • burning
  • discomfort
  • discharge
  • promotes healing of the vaginal mucosa
Dosage and Administration

Directions

  • Before using YeastCalm vaginal suppository, read the enclosed educational insert for complete instructions and information.
  • Adults 12 years of age and older: Insert one YeastCalm vaginal suppository high into the vagina at bedtime for 7 consecutive nights. Applicator is included.
  • Children under 12 years of age: Ask a doctor.
Description

Active Ingredients** (in each suppository) Borax 14X HPUS (0.15 g) Calendula officinalis 1X HPUS (0.15 g) Candida albicans 30X HPUS (0.15 g) Hydrastis canadensis 5X HPUS (0.15 g) (contains less than 10 -3 hydrastine and berberine alkaloids) The letters "HPUS" indicate that the components in the product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5
  • do not use if the suppository mold seal is broken
  • do not store above 86° F (30° C)
  • retain this carton for full drug facts

Yeast Infection Symptoms*

Minor Vaginal Itching Discharge Burning*

7 Suppositories

Applicator and educational insert included

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • symptoms do not improve in 3 days
  • symptoms remain after 7 days
  • you get abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge, or hives. These may be signs that this product is not working, or you may have a more serious condition, or allergic reaction.
Section 50567-7

When using this product

  • do not use tampons, douches, spermicides or other vaginal products
  • do not have vaginal intercourse (sex)
Section 50569-3

Ask a doctor before use if you

  • have vaginal itching and discomfort for the first time
  • have one or more of the following: abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling discharge
  • get vaginal yeast infections often (such as once a month or three in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes, or a weakened immune system.
  • may have been exposed to the human immunodeficiency virus (HIV) that causes AIDS
  • are under 12 years of age.

Section 51727-6

gelatin, glycerin, purified water

Section 51945-4

Section 53413-1

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

Section 53414-9

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

Section 55105-1

Purpose*

Borax 14X HPUS (0.15 g) ... Relieves thick vaginal discharge

Calendula officinalis 1X HPUS (0.15 g) ... Healing agent for vaginal mucosa

Candida albicans 30X HPUS (0.15 g) ... Relieves symptoms of yeast infections

Hydrastis canadensis 5X HPUS (0.15 g) ... Reduces vaginal discharge

Section 55106-9

Active Ingredients** (in each suppository)

Borax 14X HPUS (0.15 g)

Calendula officinalis 1X HPUS (0.15 g)

Candida albicans 30X HPUS (0.15 g)

Hydrastis canadensis 5X HPUS (0.15 g) (contains less than 10 -3 hydrastine and berberine alkaloids)

The letters "HPUS" indicate that the components in the product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Structured Label Content

Indications and Usage (34067-9)

Uses*

  • if this is the first time you have vaginal itching and discomfort, see your doctor to find out if you have a vaginal yeast infection
  • temporarily relieves symptoms of vaginal yeast infection (candidiasis) such as:

  • minor vaginal itching
  • burning
  • discomfort
  • discharge
  • promotes healing of the vaginal mucosa
Dosage and Administration (34068-7)

Directions

  • Before using YeastCalm vaginal suppository, read the enclosed educational insert for complete instructions and information.
  • Adults 12 years of age and older: Insert one YeastCalm vaginal suppository high into the vagina at bedtime for 7 consecutive nights. Applicator is included.
  • Children under 12 years of age: Ask a doctor.
Warnings and Precautions (34071-1)

For vaginal use only. This product will not cure a yeast infection.

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

YeastCalm vaginal suppository may damage condoms and diaphragms and cause them to fail.

Section 42229-5 (42229-5)
  • do not use if the suppository mold seal is broken
  • do not store above 86° F (30° C)
  • retain this carton for full drug facts

Yeast Infection Symptoms*

Minor Vaginal Itching Discharge Burning*

7 Suppositories

Applicator and educational insert included

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • symptoms do not improve in 3 days
  • symptoms remain after 7 days
  • you get abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge, or hives. These may be signs that this product is not working, or you may have a more serious condition, or allergic reaction.
Section 50567-7 (50567-7)

When using this product

  • do not use tampons, douches, spermicides or other vaginal products
  • do not have vaginal intercourse (sex)
Section 50569-3 (50569-3)

Ask a doctor before use if you

  • have vaginal itching and discomfort for the first time
  • have one or more of the following: abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling discharge
  • get vaginal yeast infections often (such as once a month or three in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes, or a weakened immune system.
  • may have been exposed to the human immunodeficiency virus (HIV) that causes AIDS
  • are under 12 years of age.

Section 51727-6 (51727-6)

gelatin, glycerin, purified water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose*

Borax 14X HPUS (0.15 g) ... Relieves thick vaginal discharge

Calendula officinalis 1X HPUS (0.15 g) ... Healing agent for vaginal mucosa

Candida albicans 30X HPUS (0.15 g) ... Relieves symptoms of yeast infections

Hydrastis canadensis 5X HPUS (0.15 g) ... Reduces vaginal discharge

Section 55106-9 (55106-9)

Active Ingredients** (in each suppository)

Borax 14X HPUS (0.15 g)

Calendula officinalis 1X HPUS (0.15 g)

Candida albicans 30X HPUS (0.15 g)

Hydrastis canadensis 5X HPUS (0.15 g) (contains less than 10 -3 hydrastine and berberine alkaloids)

The letters "HPUS" indicate that the components in the product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Advanced Ingredient Data


Raw Label Data

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