NDC | 68093-7247-1 |
Set ID | de4dc2a2-b829-4b1b-8813-94700315a7bc |
Category | HUMAN OTC DRUG LABEL |
Packager | Wisconsin Pharmacal Company |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- 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.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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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)