FDA.reportPublic FDA data

FDA label c27a418c-c9f9-405c-aa3c-bf6e7aebfd1b

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
26db80da-7046-4fba-adf9-4da46069cbdd
SPL ID
c27a418c-c9f9-405c-aa3c-bf6e7aebfd1b
Version
3
Effective date
2011-06-22
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:36

Boxed warning cross-check#

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Boxed warning sections page 1 of 1 · 1 matching rows.

boxed warning

BOXED WARNING See full prescribing information for complete boxed warning. • Diagnosis: Hand and or Foot pain requires differential diagnosis for primary nerve pain, post-traumatic pain, or pain due to bone fractures, or post fracture pain. • Treatment: Skin disinfection is required before injection. See full prescribing information for complete boxed warning. • Diagnosis: Hand and or Foot pain requires differential diagnosis for primary nerve pain, post-traumatic pain, or pain due to bone fractures, or post fracture pain. • Treatment: Skin disinfection is required before injection. ( 5 )

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

5. WARNINGS AND PRECAUTIONS 5.1. Hand/Foot pain requires differential diagnosis for primary nerve pain, post-traumatic pain, pain due to bone fractures, or post fracture pain. 5.2. In rare cases patients may experience hypersalivation within one hour of treatment. Discontinue treatment. The hypersalivation resolves over several hours without further medical treatment. 5.3. Skin cleansing/disinfection is required before application. Saprophytic bacteria may produce injection site abscesses with improper skin preparation. Diagnosis: Hand/Foot pain requires differential diagnosis for primary nerve pain, post-traumatic pain, secondary pain due to present or previous bone fracture. Treatment: Skin disinfection is required before and after injection. In rare cases patients may experience hypersalivation within one hour of treatment. Discontinue treatment. The hypersalivation resolves over several hours without further medical treatment. ( 5 )

Adverse reactions cross-check#

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adverse reactions

6. ADVERSE REACTIONS 6.1. The most common mild adverse reaction is slight reddening at the injection site due to the mechanical effect of the needle or a superficial skin reaction of mild erythema. The most common mild adverse reaction is slight reddening at the injection site due to mechanical effect of the needle or a superficial skin reaction of mild erythema. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GUNA Inc. at 1-888-GUNA-TEL (486-2835) or www.gunainc.com Or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Reported adverse events (FAERS/openFDA)#

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