FDA label bfe8edeb-a494-4ca0-b9e8-9155786129f0

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
29db09f4-8aa5-4b4d-a409-34c5d6b4b0e7
SPL ID
bfe8edeb-a494-4ca0-b9e8-9155786129f0
Version
2
Effective date
2017-11-18
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:49

Boxed warning cross-check#

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Boxed warning sections page 1 of 1 · 1 matching rows.

boxed warning

6 With one hand holding the barrel, use the other hand to push the plunger all the way in to place the cream as far back in the vagina as possible. Then remove both parts of the applicator from the vagina. 7 Be sure to clean the applicator after each use. Gently pull apart the applicator pieces. Wash them with soap and warm water. To rejoin, gently push the inside piece into the ribbed end of the outside piece as far as it will go. 8 Lie down as soon as possible after inserting the cream. This will reduce leakage. 9 Repeat steps 2 through 8 before bedtime for the next 6 days. You may want to use deodorant-free pads or pantyshields to protect your clothing during the time that you are using this product. This is because the vaginal cream can leak or you may get some discharge. Do not use tampons, douches, spermicides, condoms or diaphragms until after you have completed the treatment and your symptoms are gone.

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor 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 the human immunodeficiency virus (HIV) that causes AIDS Ask a doctor or pharmacist before use if you are taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur 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 diseases (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 in 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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