FDA label 9ddddb0b-5cb1-42be-98d0-55c4a0fec2e5

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: 6e80bda7-31a7-46c1-b49d-1554fc1ee6e5
SPL ID: 9ddddb0b-5cb1-42be-98d0-55c4a0fec2e5
Version: 2
Effective date: 2015-06-25
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 02:07:26

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		9ddddb0b-5cb1-42be-98d0-55c4a0fec2e5	id
spl set id		6e80bda7-31a7-46c1-b49d-1554fc1ee6e5	set_id

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. Use only as directed. Avoid contact with eyes and mucous membranes. Do not cover with bandage. Do not use on wounds or damaged skin. Consult physician for children under 12. Do not use if you are allergic to Menthol. Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days or rash, itching or excessive skin irritation occurs. KEEP OUT OF REACH OF CHILDREN.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS To report adverse side effects or to obtain product information, contact Allegis Pharmaceuticals, LLC at 1-866-633-9033.

Reported adverse events (FAERS/openFDA)#

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