FDA.reportPublic FDA data

Yeast Gard Advanced

Manufacturer
Wisconsin Pharmacal Company
Effective date
2018-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:10:34

Label at a glance#

ProductYeast Gard Advanced
Active ingredientHAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, BERBERIS VULGARIS ROOT BARK, SODIUM BORATE, COLLINSONIA CANADENSIS ROOT
Label structure9 sections

Indications and uses

Uses For the temporary relief of symptoms associated with vagianl yeast infection, including: itching burning irritation

Dosage and administration

Directions Tamper Evident: If the foil seal on bottle opening is missing, torn or damaged in any way, do not use. Wash hands thoroughly with soap and water before and after use remove cap and safety seal from bottle. Carefully open teh packet and pour homeopathic contents into the douche bottle. Screw cap back onto bottle and shake thoroughly to fully mix powder into solution. After fully mixed, remove cap. Remove...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Borax 3X HPUS
Collinsonia Canadensis 3X HPUS
Berberis Vulgaris 6X HPUS
Hamamelis Virginiana 6X HPUS

OTC - PURPOSE SECTION

Purpose

Temporary relief from vaginal itching, burning and irritation

Uses

INDICATIONS & USAGE SECTION

Uses For the temporary relief of symptoms associated with vagianl yeast infection, including:

  • itching
  • burning
  • irritation

Warnings

WARNINGS SECTION

  • Use only as directed
  • For vaginal use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Vaginal itching and discomfort for the first time
  • Lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a serious condition.
  • Vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for you symptoms, including diabetes or a weakened immune system.
  • Been exposed to the human immunodeficiency virus (HIV) that causes AIDS
  • You have an STD (sexually transmitted disease) or PID (Pelvic inflammatory disease)
  • You have frequent and painful urination

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • Symptoms last more than 7 days
  • You get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vagina.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - DO NOT USE SECTION

Do not use

  • if you have never had a vaginal yeast infection diagnosed by a doctor

OTC - WHEN USING SECTION

When using this product

  • if you do not get complete relief ask a doctor before using another product

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Tamper Evident: If the foil seal on bottle opening is missing, torn or damaged in any way, do not use.

  • Wash hands thoroughly with soap and water before and after use
  • remove cap and safety seal from bottle. Carefully open teh packet and pour homeopathic contents into the douche bottle. Screw cap back onto bottle and shake thoroughly to fully mix powder into solution. After fully mixed, remove cap. Remove sanitary wrap from nozzle. Screw nozzle onto douche bottle.
  • Slowly insert nozzle into vagina about 3 inches. If needed, a small amount of personal lubricant can be applied to nozzle to ease insertion of nozzle into vagina. Gently squeeze bottle until solution is dispensed. Use while sittion on the toilet, standing in the shower or in the tub. After douching discard bottle and nozzle.

OTHER SAFETY INFORMATION

Other information

  • a douche is not a contraceptive and should not be used to prevent pregnancy
  • do not use if foil seal on bottle opening is missing, torn damaged in any way. use if homeopathic packet is torn, open or incompletely sealed. purchase if carton is open
  • Store at room temperature
  • Lot number and expiration date: see upper back panel of box
  • There is no scientific evidence that this product works. Ther product claims are based on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bacillus coagulans, citric acid, edetate disodium, maltodextrin, purified water, sodium benzoate, sodium lauryl sulfate, trisodium phosphate

OTC - QUESTIONS SECTION

Questions or commetns? 1-800-635-3696

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68093-0668-1Yeast Gard Advanced133.07 g in 1 BOTTLEDOUCHE133.072
68093-0668-1Yeast Gard Advanced2 in 1 CARTONDOUCHE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68093-0668YEAST GARD ADVANCED (BERBERIS VULGARIS, BORAX, COLLINSONIA CANADENSIS, HAMAMELIS VIRGINIANA) DOUCHE [WISCONSIN PHARMACAL COMPANY]2Current NDC, Legacy NDC, 2 package rows20181212_0dfe58cd-713c-4a0d-88e2-1604fe13292a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68093-066868093-0668-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
BACILLUS COAGULANSISK1LOY57EIACT
EDETATE DISODIUM7FLD91C86KIACT
MALTODEXTRIN7CVR7L4A2DIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOACTIB
COLLINSONIA CANADENSIS ROOTO2630F3XDRACTIB
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Yeast Gard AdvancedBERBERIS VULGARIS, BORAX, COLLINSONIA CANADENSIS, HAMAMELIS VIRGINIANAWisconsin Pharmacal Company0dfe58cd-713c-4a0d-88e2-1604fe13292a2018-12-06WarningsExact identifier
ndc (package): 68093-0668-1
ndc (product): 68093-0668
ndc11 (package): 68093066801
spl id: 7c5d8463-5311-a397-e053-2991aa0abc29
spl set id: 0dfe58cd-713c-4a0d-88e2-1604fe13292a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.