FDA label 0d766155-d1a0-7bf3-e063-6394a90a17b6

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
3af92554-6c82-4fa0-bfff-a2055293726b
SPL ID
0d766155-d1a0-7bf3-e063-6394a90a17b6
Version
5
Effective date
2023-12-26
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:55:00

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 (For external use only) Do not use this product if Pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Tamper Evident "Warranty Void...Seal...label atop the container is broken." When using this product Do not exceed the recommended daily dosage unless directed by a doctor. Certain persons can develop allergic reactions to ingredients in this product. Do not put this product into the rectum by using fingers or any medical device or applicator. Stop use and ask a doctor if The symptom being treated does not subside or if redness, irritation, swellinh, pain, or other symptoms develop or increase. Keep out of reach of children In case of accidental ingestion, seek medical attention immediately. Directions Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply up to 6 times a day. Children under 12 years of age: consult a doctor. Other Information Keep away from direct sunlight or heat Store in room temperature (59-86 ​0 ​F / 15-30 ​0 ​C) Inactive Ingredients Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ehtoxydiglycol, Lecithin, Neopentyl Glycol Dicarprylate/Dicarpate, Sodiuym Polyacrylate, Hydrogenated Polydecene, Trideceth-10, Cholesterol, Allantoin

Reported adverse events (FAERS/openFDA)#

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