KENALOG 40 Injection

Hazard statements (CLP)

H361fd, H373

Code

Statements

H361fd

Suspected of damaging fertility; Suspected of damaging the unborn child

SECTION 2: Hazards identification

WHMIS 2015 Classification of the substance or mixture Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Consult prescribing/packaging information. The classification and labeling listed below is for bulk drug product Reproductive toxicity Category 2 Suspected of damaging fertility. Suspected of damaging the unborn child Specific target organ toxicity (repeated exposure) Category 2 May cause damage to organs (endocrine system) through prolonged or repeated exposure

Signal word

Warning

Hazard statements

H361fd - Suspected of damaging fertility. Suspected of damaging the unborn child. H373 - May cause damage to organs (endocrine system) through prolonged or repeated exposure

Precautionary statements

P201 - Obtain special instructions before use. P260 - Do not breathe dust/fume/gas/mist/vapors/spray. P280 - Wear protective gloves/protective clothing/eye protection/face protection. P308+P313 - If exposed or concerned: Get medical advice/attention. P314 - Get medical advice/attention if you feel unwell. P405 - Store locked up. P501 - Dispose of contents/container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. Long Grove Pharmaceuticals, LLC. - Triamcinolone Acetonide Injectable Suspension, 40 mg/mL Page 1 of 7 Revision Date: 23 May 2022,Version 2.0

2.3 Other hazards

Triamcinolone acetonide is a synthetic glucocorticosteroid which acts similarly to the endogenously produced hormone cortisol. Long-term topical use of triamcinolone has been associated primarily with depigmentation and/or atrophy of the skin. The most common effects seen following inhalation use are headache and sore throat. Adverse effects caused by prolonged or excessive systemic exposure to corticosteroids as a class can include: increased blood pressure, metabolic imbalance, suppression of the hypothalamic-pituitary adrenal axis (which may result in a syndrome characterized by weight gain, skin changes, excessive hair growth, menstrual irregularities, and decreased libido,), increased infections, and psychological effects (e.g., mood swings, euphoria, or insomnia). Sudden withdrawal may cause adrenal insufficiency, characterized by joint and/or muscular pain, lethargy, and depression. Corticosteroid use by male patients can cause decreased sperm count and sperm motility. Evidence of teratogenicity has been seen in animals; however, no congenital malformations were reported in the offspring of women treated with systemic or topical triamcinolone during pregnancy. Note This mixture is classified as hazardous under GHS as implemented by Regulation EC No

2.1 Classification of the substance or mixture

Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Consult prescribing/packaging information. The classification and labeling listed below is for bulk drug product. Reproductive toxicity Category 2 Suspected of damaging fertility. Suspected of damaging the unborn child. Specific target organ toxicity (repeated exposure) Category 2 May cause damage to organs (endocrine system) through prolonged or repeated exposure