FDA label 4dd0d088-bd32-4903-9e0c-d528a28f3cb3

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
d0717302-04a2-46b5-8834-238d2f5cba36
SPL ID
4dd0d088-bd32-4903-9e0c-d528a28f3cb3
Version
2
Effective date
2017-12-08
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:08:18

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

WARNINGS Warnings: For external use only 1. Please discontinue use immediately in the event that you experience any of the following side effects from using this product, and consult a dermatologist as the symptoms may get worse with continued use. (a) Adverse skin reactions occur upon its application which may involve red spots, swelling, itchiness, and other skin irritation. (b) The applied part shows signs of any of the symptoms mentioned above after exposure to the direct sunlight. 2. Do not apply to wounds and the area affected by dermatitis, eczema, and other irritations. 3. Precautions for handling and storage (a) Always close the cap after each use. (b) Always keep the product out of the reach of infants. (c) Do not store the product in high and low temperatures. It should also be kept out of direct sunlight. 4. Vulvar Cleanser (a) It should only be used on the vulva. (b) It should not be used for long periods of time. (c) It should be used with extreme caution when there are affected areas on the (vulvar) skin or the surrounding area has become contaminated. (d) It should not be used on children under 3 years of age. (e) It is not recommended for use during pregnancy and it is advised that you discontinue its use on the vulva until you deliver a baby as it may get into the eyes of the newborn baby.

Reported adverse events (FAERS/openFDA)#

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