YEASTCALM- sodium borate,calendula officinalis flowering top,candida albicans,goldenseal suppository

YeastCalm by

Drug Labeling and Warnings

YeastCalm by is a Homeopathic medication manufactured, distributed, or labeled by Laboratoires Boirdon, Boiron Inc., Boiron. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

PURPOSE

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

INDICATIONS & 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

WARNINGS

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.

ASK DOCTOR

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.

WHEN USING

When using this product

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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.

INACTIVE INGREDIENT

gelatin, glycerin, purified water

QUESTIONS

BoironUSA.com

Info@Boiron.com

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

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

• 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

YEASTCALM 
sodium borate,calendula officinalis flowering top,candida albicans,goldenseal suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9376
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	5 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	14 [hp_X]
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	30 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9376-62	7 in 1 BOX; Type 0: Not a Combination Product	10/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/01/2021

Labeler - Laboratoires Boirdon (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9376)