Label: TIOCONAZOLE OINTMENT 6.5%- tioconazole ointment
- NDC Code(s): 63094-0426-1
- Packager: DPT Laboratories, Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
(i n each applicator)
Tioconazole 300 mg (6.5%)
vaginal antifungal Close
- treats vaginal yeast infections
For vaginal use only
- DO NOT USE
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Close
- 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 more 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 your symptoms, including diabetes or a weakened immune system.
- been exposed to human immunodeficiency virus (HIV) that causes AIDS
- When using this product
- do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs).
- do not have vaginal intercourse
- mild increase in vaginal burning, itching or irritation may occur
- Stop use and ask a doctor if
- symptoms do not get better after 3 days
- symptoms last more than 7 days
- you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use. Close
- 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. Close
- before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
- adults and children 12 years and over: 1.Open the foil packet just before use and remove purple cap. 2.Insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.
- children under 12 years of age: ask a doctor
- Other information
- this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days.
- if you have questions about vaginal yeast infections, consult your doctor
- store at 20 - 25°C (68 - 77°F)
- see end flap of carton for lot number and expiration date
- Inactive ingredients
butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum Close
- INDICATIONS & USAGE
Do not use if sealed foil packet torn, open, or incompletely sealed.
TIOCONAZOLE OINTMENT 6.5%
DIRECTIONS FOR USE
- Tear open foil packet just before using. It is best to use at bedtime.
- Remove applicator and plunger from packet. Applicator is prefilled with vaginal ointment.
- While firmly holding the purple-capped end of the applicator, push the tip of the plunger into the base of applicator.
REMOVE PURPLE CAP from top of applicator with a pull-twist action.
Insert the applicator
- Lie on your back with your knees bent. Gently insert applicator into the vagina as far as it will go comfortably.
- Push the plunger into the applicator until it will go no farther. Withdraw the applicator and plunger and dispose of it in the wastebasket. Do not flush.
- DO NOT USE TAMPONS while using this medicine. Use sanitary napkins instead.
PLEASE READ EDUCATIONAL BROCHURE FOR ADDITIONAL INFORMATION.
ALLEGAN, MI 48010 U.S.A.
- INGREDIENTS AND APPEARANCE
TIOCONAZOLE OINTMENT 6.5%
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63094-0426 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TIOCONAZOLE (UNII: S57Y5X1117) (TIOCONAZOLE - UNII:S57Y5X1117) TIOCONAZOLE 65 mg in 1 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63094-0426-1 5 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075915 08/22/2007 Labeler - DPT Laboratories, Ltd. (621782218) Registrant - DPT Laboratories, Ltd. (621782218) Establishment Name Address ID/FEI Business Operations DPT Laboratories, Ltd. 621782218 manufacture