FDA label a53ea205-e715-4613-b0f1-ce91b9c67929

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
1d14b698-0cdf-4f8f-b4cc-6f82f1fb01e7
SPL ID
a53ea205-e715-4613-b0f1-ce91b9c67929
Version
1
Effective date
2015-11-23
Source export date
2026-11-06
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:28:48

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: 1. Stop using the product immediately if any of following symptoms appears, and consult a dermatologist as continuing to use the product may worsen the symptoms. 1) Red spots, swelling, itching or irritations during use 2) If above symptoms appeared to the applied area due to direct sunlight 2. Do not use on areas with scars, eczema or dermatitis 3. Storage and handling precautions 1) Close the lid after use 2) Keep away from the reach of children 3) Avoid storing high/low temperature and direct sunlight 4. Precautions during use 1) Use only on the vulva 2) Do not use the product for a prolonged period of time 3) Be careful if the affected area or the surrounding area is dirty 4) Do not use on children under 3 years of age 5) Avoid using during pregnancy and prior to the delivery as it may get into the newborn’s eyes during delivery

Reported adverse events (FAERS/openFDA)#

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