FDA label 9adde184-b4c5-4dfd-b2e0-a30ee8caff08

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
cf62370a-9a10-46b1-b320-23eaf196040c
SPL ID
9adde184-b4c5-4dfd-b2e0-a30ee8caff08
Version
1
Effective date
2015-07-30
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:16:36

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 - if you are allergic to any ingredient in this product - during pregnancy or breast-feeding. When using this product - avoid contact with eyes - apply only to affected areas - avoid applying directy inside your mouth - do not share this product with anyone. This may spread infection. - dispose cotton swab immediately after use - discard after 1 month of opening the tube Stop use and ask a doctor if - condition worsens - symptoms last more than 7 days - symptoms clear up and return in a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions ​adults and children 12 years or over: ​ - Apply to affected area on face or lips at first sign (tingle) of cold sore/fever blister - Open tube, saturate cotton swab with 8 drops of liquid - Use the cotton swab to apply to affeted area on face or lips. Do ot touch the sore with your fingers. Continue for 3 seconds until the cold sore is completely covered and sealed. - Dispose of cotton swab - do not reuse - Wash hands before and after application. - Apply 2 times daily, not to exceed 3 to 4 times daily until sore is healed ​children under 12 years: ask a doctor

Reported adverse events (FAERS/openFDA)#

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