FDA Label for Yeastcalm
View Indications, Usage & Precautions
Yeastcalm Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoires Boirdon. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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.
Otc - 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
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. YeastCalm may damage condoms and diaphragms and cause them to fail.
Otc - Ask Doctor
- have one or more of the following: abdominal pain, fever, chills, nausea, vomiting, or foul-smelling discharge
- get vaginal yeast infections often (such as once a month or three in 6 months)
- may have been exposed to the human immunodeficiency virus (HIV) that causes AIDS
- are under 12 years of age.
Otc - When Using
When using this product
- do not use tampons, douches, or spermicides
- do not have vaginal intercourse (sex).
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - 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, 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
gelatin, glycerin, purified water
Otc - Questions
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
Other
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.
* Please review the disclaimer below.