warnings
Warning: FOR VAGINAL USE ONLY. USE AS DIRECTED BY A PHYSICIAN. NOT TO BE TAKEN ORALLY. KEEP OUT OF REACH OF CHILDREN. If accidentally swallowed, seek medical help or contact the Poison Control Center immediately.
FDA label 6a591452-a95b-4292-b0ca-745f5828d570
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
- SPL set ID
- 59f2f192-b9e3-4425-a754-b8c4f5007427
- SPL ID
- 6a591452-a95b-4292-b0ca-745f5828d570
- Version
- 3
- Effective date
- 2022-12-15
- Source export date
- 2026-10-12
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:05:20
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 6a591452-a95b-4292-b0ca-745f5828d570 | id | |
| spl set id | 59f2f192-b9e3-4425-a754-b8c4f5007427 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings table
<table width="100%"><caption/><tbody><tr styleCode="First Last"><td styleCode="Lrule Rrule Toprule Botrule"><paragraph><content styleCode="italics"><content styleCode="bold">Warning:</content></content></paragraph><paragraph><content styleCode="bold">FOR VAGINAL USE ONLY. USE AS DIRECTED BY A PHYSICIAN. NOT TO BE TAKEN ORALLY.</content></paragraph><paragraph><content styleCode="bold">KEEP OUT OF REACH OF CHILDREN.</content> If accidentally swallowed, seek medical help or contact the Poison Control Center immediately.</paragraph></td></tr></tbody></table>
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS AND SIDE EFFECTS Hylafem’s ingredients are generally safe when used as directed, but there is no known information about the safety of its long-term use. Boricum Acidum 2X is equivalent to 0.025mg of Boric Acid per capsule. In most recent research, no serious side effects were reported when boric acid was used as a short course treatment for vaginitis. The adverse effects are considered mild and may include watery discharge, erythema, or a slight burning sensation or a gritty sensation with intercourse during the treatment period. Note: It is advised to avoid sexual intercourse during treatment period. You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P. O. Box 360465 Decatur GA 30036 or at website: www.uspco.com.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.