FDA.reportPublic FDA data

FDA label 110577bb-cb52-7137-e054-00144ff8d46c

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
11059b43-1b8a-47fa-e054-00144ff8d46c
SPL ID
110577bb-cb52-7137-e054-00144ff8d46c
Version
3
Effective date
2015-03-11
Source export date
2026-08-01
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/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:09:00

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

Boxed Warning Section WARNING: For Vaginal use only. Not for rectal (anal) use. Do not take orally. If irritation is experienced by either of the partner, discontinue use if irritation persist, consult your physician. This product does not protect against HIV AIDS or other STDs and may increase the risk of getting HIV from an infection partner. Do not use if you or your sex partner has HIV AIDS. if you do not know if you or your partner is infected, choose another form of birth control. When using this you may get vaginal irritation (burning, itching, or a rash). Stop Using and ask a Doctor if you or your partner get burning, itching, a rash or other irritation of the vagina or penis. Keep this and all medicines out of reach of children.

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warning WARNING: For Vaginal use only. Not for rectal (anal) use. Do not take orally. If irritation is experienced by either of the partner, discontinue use if irritation persist, consult your physician. This product does not protect against HIV AIDS or other STDs and may increase the risk of getting HIV from an infection partner. Do not use if you or your sex partner has HIV AIDS. if you do not know if you or your partner is infected, choose another form of birth control. When using this you may get vaginal irritation (burning, itching, or a rash). Stop Using and ask a Doctor if you or your partner get burning, itching, a rash or other irritation of the vagina or penis. Keep this and all medicines out of reach of children.