Label: YEASTCALM- sodium borate,calendula officinalis flowering top,candida albicans,goldenseal suppository
- NDC Code(s): 0220-9376-62
- Packager: Laboratoires Boirdon
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated April 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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.
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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 Candida (yeast) infections
Hydrastis canadensis 5X HPUS (0.15 g) ... Reduces vaginal discharge
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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
- ASK DOCTOR
- WHEN USING
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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 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
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Before using YeastCalm, read the enclosed educational insert for complete instructions and information.
- Adults and children 12 years of age and older: Insert one YeastCalm suppository high into the vagina every night for 7 consecutive nights. Applicator is included.
- Children under 12 years of age: Ask a doctor.
- INACTIVE INGREDIENT
- QUESTIONS
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SPL UNCLASSIFIED SECTION
do not use if the suppository mold seal is broken
do not store above 77° F (25° C)
Yeast Infection*
Minor Vaginal Itching Discharge Burning*
Relieves & Heals
No Parabens
No Preservatives
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
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INGREDIENTS AND APPEARANCE
YEASTCALM
sodium borate,calendula officinalis flowering top,candida albicans,goldenseal suppositoryProduct 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)
