FDA label 77d64b26-554d-4658-b837-298d03df5e5e

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
027a044b-3275-43bd-9a18-38bf636a0e0f
SPL ID
77d64b26-554d-4658-b837-298d03df5e5e
Version
1
Effective date
2020-04-13
Source export date
2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:22:48

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. Do not use the product on the following areas : Around the eyes and ears, in the mouth, large body part and damaged skin(it may cause irritation.) 2. If you suffer from the next symptom, discontinue use of the product immediately and consult a physician or pharmacist. 1) Hypersensitivity symptoms e.g. rash, erythema, itchiness, and edema 2) Skin irritation symptoms 3. Other precautions 1) For external use only. (Do not swllow.) 2) Avoid contact with eyes. If it contacts with eyes, wash with clean clean water and consult a physician or a pharmacist. 3) Be careful not to inhale vapors in case of using for a long time. (In case of inhaling large amounts of ethanol vapor, it may cause irritation of the mucous membranes and headaches.) (Limited to ethanol-containing the product) 4) If you use this product on the same area repeatedly, cure should be provided as the skin may become rough due to excessive oil removal. 5) Do not use sealed bandages, cast bandages, or packs as they many cause irritation. 6) Do not use this drug on the anal or vagina areas, or with hot packs, as it may cause irritation or chemical burns. 7) Use only for the intended purpose. 4. Precaution for storage 1) Keep away from direct sunlight and do not expose the product to heating devices or flame. 2) Let the children not touch this drug and in case of swallowing it, go to the hospital immediately. 3) After use. close the lid completely and prevent the product from drying or foreign objects from getting inside the container. 4) In case of keeping the product on the different container, it may cause accidents or deterioration of quality.

Reported adverse events (FAERS/openFDA)#

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