FDA label 066efaf4-bead-4741-8fbd-3f8605876380

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
a5e772c2-7001-4e55-8dba-669ad222496c
SPL ID
066efaf4-bead-4741-8fbd-3f8605876380
Version
3
Effective date
2017-11-08
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:32:45

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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

boxed warning

How Should I Use This Product? This product is for adults and children 12 years of age and over. For children under 12 years, ask a doctor. Directions for using the Applicators containing Vaginal Cream: Begin treatment before going to bed: 1 Remove the prefilled applicator from the wrapper. 2 Unscrew and remove violet cap from prefilled applicator. 3 Insert plunger into prefilled applicator by placing small end of plunger into the ribbed end of the applicator. 4 Gently insert the applicator into the vagina as far as it will go comfortably. This can be done while lying on your back with your knees bent (as shown in the picture) or while standing with your feet apart and your knees bent. 5 With one hand holding the barrel use the other hand to push the plunger as far into the barrel as it will go. Remove both parts of the applicator from the vagina. 6 Throw the applicator away after use. Do not flush it down the toilet. 7 Lie down as soon as possible after inserting the cream. This will reduce leakage. 8 Repeat steps 1 through 7 before going to bed for the next 2 days. You may want to use deodorant-free minipads or pantyshields to protect your clothing during the time that you are using this product. This is because the cream can leak or you may get some discharge. Do not use tampons,douches, or spermicides until after you have completed treatment and your symptoms are gone. image 1 Image 2

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.