Label: YEAST GARD HOMEOPATHIC GEL HOMEOPATHIC GEL TREATMENT- borax, collinsonia canadensis, berberis vulgaris, hamamelis virginiana gel
- NDC Code(s): 68093-7247-1
- Packager: Wisconsin Pharmacal Company
- 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 December 6, 2018
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- Active Ingredients
- PURPOSE
- INDICATIONS & USAGE
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Warnings
For external vaginal use only. Use only as directed.
Keep out of reach of children. If swallowed, get medial help or contact a Poison Control Center right away. If in eyes, flush with water for 15 minutes and call a physician.
Stop use and ask doctor if
- Symptoms worsen, last more than 7 days, or clear up and occur again within a few days.
- You get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.
When using this product
- Wash hands thoroughly with soap and water before and after use
- Avoid contact with eyes
- If burning sensation occurs and lasts more than a few minutes, remove gel and discontinue use
- Do not use more than one week unless directed by a doctor
- If yoyu do not get complete relief ask a doctor before using another product.
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
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Directions
Directions
- Apply to affected area as often as needed. Because the area is irritated, you could experience a slight burning sensation. If this persists more than a few minutes, remove gel and discontinue use.
- Wash hand thoroughly with soap an dwater before and after use.
- Do not use for children under two years. Consult a doctor if condition persists.
- Inactive Ingredients
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Other Information
Other information
- Do not use if safety seal under cap is missing or broken
- Store at room temperature
- Lot number and expiration date: see date on tube and box flap.
- Retain carton for complete Drug Facts Warnings
- 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.
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INGREDIENTS AND APPEARANCE
YEAST GARD HOMEOPATHIC GEL HOMEOPATHIC GEL TREATMENT
borax, collinsonia canadensis, berberis vulgaris, hamamelis virginiana gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68093-7247 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6 [hp_X] in 1 g COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT 3 [hp_X] in 1 g SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE 3 [hp_X] in 1 g BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength PROPANEDIOL (UNII: 5965N8W85T) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM BENZOATE (UNII: OJ245FE5EU) GLUCONOLACTONE (UNII: WQ29KQ9POT) EDETATE DISODIUM (UNII: 7FLD91C86K) ALLANTOIN, (+)- (UNII: XDK458E1J9) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) WATER (UNII: 059QF0KO0R) POLYSORBATE 20 (UNII: 7T1F30V5YH) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68093-7247-1 1 in 1 CARTON 04/01/2007 1 28.35 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/01/2007 Labeler - Wisconsin Pharmacal Company (800873986) Establishment Name Address ID/FEI Business Operations Wisconsin Pharmacal Company 800873986 manufacture(68093-7247)
