boxed warning
BOXED WARNING WARNING – Skin disinfection is required before and after application See full prescribing information for complete boxed warning. •Skin disinfection is required before and after injection. ( 5 )
FDA label bdabd0b3-8130-4034-a23a-376c48054748
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
- SPL set ID
- e6d44cdd-40a0-4442-93f9-5a5451d84af1
- SPL ID
- bdabd0b3-8130-4034-a23a-376c48054748
- Version
- 2
- Effective date
- 2011-06-23
- Source export date
- 2026-10-12
- 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/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:30:25
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | bdabd0b3-8130-4034-a23a-376c48054748 | id | |
| spl set id | e6d44cdd-40a0-4442-93f9-5a5451d84af1 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
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warnings and cautions
5. WARNINGS AND PRECAUTIONS 5.1. Be sure to disinfect the area before application. After treatment, avoid alcohol containing disinfectants as they produce local irritation that appears unpleasant on face. In most cases, the slight irritation disappears within 2 hours. 5.2. Skin cleansing/disinfection is required before application. Saprophytic bacteria may produce injection site abscesses with improper skin preparation. Skin cleansing: •Be sure to disinfect the area before application. After treatment, avoid alcohol-containing disinfectants as they produce local irritation that appears unpleasant on the face. In most cases, the slight irritation disappears within 2 hours. •Saprophytic bacteria (i.e. atypical mycobacteria, staphylococcus genus) may be present on skin or in makeup products. When injection treatments are performed, bacteria introduced beneath the skin may produce local infection (injection site abscesses), which appear as little red spots. Skin disinfection helps prevent this problem. ( 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 the mechanical effects of the needle or a superficial skin reaction of mild erythema. To report SUSPECTED ADVERSE REACTIONS, contact GUNA Inc. at 1-888-GUNA-TEL (4862-835) or www.gunainc.com Or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ( 6 )
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.