Product Name: Miconazole Nitrate
Chemical Name: 1-[2,4-Dichloro-β-(2,4-dichlorobenzyloxy)phenethyl]imidazole nitrate
Synonyms: Monistat, Daktarin, Micatin
CAS Number: 22832-87-7
Recommended Use: Antifungal medication for topical or oral use, suited for treatment of fungal infections
Manufacturer’s Details: Information available from safety documentation provided by main pharmaceutical producers
Emergency Contact: Refer to local poison center or regional health authority
Classification: Hazardous under OSHA Hazard Communication Standard (29 CFR 1910.1200)
Hazard Statements: May cause skin, eye, and respiratory irritation; possible sensitizer in susceptible persons; potential reproductive toxicity documented in animal studies
Pictograms: Exclamation mark; health hazard symbols
Precautionary Statements: Avoid inhalation, skin, and eye contact; use protective gear; wash thoroughly after handling
Routes of Exposure: Skin absorption, inhalation, ingestion, eye contact; certain groups like allergy sufferers and pregnant persons require extra caution
Other Hazards: Not classified as carcinogenic by IARC, NTP, or OSHA based on available evidence
NFPA Ratings: Health: 2, Flammability: 0, Instability: 0
Chemical Ingredient: Miconazole Nitrate
Concentration: ≥99% in raw bulk material; product mixtures may add excipients or carriers
Impurities: Manufacturing residues below regulatory thresholds
Other Components: Substances such as starch, cellulose, or other pharmaceutical carriers used according to formulation
Inhalation: Take the person to fresh air immediately; seek medical attention if symptoms appear such as coughing, shortness of breath, or irritation of the respiratory tract
Skin Contact: Remove contaminated clothing; rinse skin with plenty of water and soap for at least fifteen minutes; get medical advice in case of persistent redness or irritation
Eye Contact: Flush eyes with water for at least fifteen minutes lifting upper and lower eyelids; do not rub eyes; consult medical help if irritation persists
Ingestion: Do not induce vomiting unless instructed by medical personnel; rinse mouth; seek medical attention if significant quantity ingested or symptoms like nausea appear
Notes to Physician: Treatment based on symptoms; consider supportive care and treat any allergic reaction or irritation
Suitable Extinguishing Media: Use water spray, dry chemical, CO2, or foam based on the nature of nearby materials
Unsuitable Extinguishing Media: Do not use high-pressure water jets due to potential for spreading powder
Specific Hazards: Product is not highly flammable though thermal decomposition may release harmful compounds such as nitrogen oxides, hydrogen chloride, carbon monoxide
Protective Equipment: Firefighters should wear self-contained breathing apparatus, chemical-resistant suit and gloves; avoid inhaling smoke fumes
Other Precautions: Move containers from fire area if safe; cool containers with water spray to prevent rupture
Personal Precautions: Avoid contact with skin, eyes, or clothing; use appropriate personal protective equipment such as gloves, goggles, lab coat, and mask
Environmental Precautions: Prevent entry into waterways, sewage, or soil to minimize environmental impact
Spill Cleanup Methods: Do not dry sweep large quantities; use damp cloth or absorbent materials; sweep up and collect into suitable closed container for disposal; ventilate area to disperse any dust
Decontamination: Wash spill area with water and detergent; dispose of cleaning materials in accordance with hazardous waste regulations
Reporting Requirements: Notify supervisory personnel as required by workplace standards
Safe Handling Practices: Wear protective gear; avoid generating dust or inhaling dust particles; wash hands thoroughly after use and before eating or drinking; refrain from smoking or eating in work area
Storage Conditions: Keep container tightly closed and in a cool, dry, well-ventilated space; store away from incompatible materials like strong acids and oxidizers; restrict access to trained personnel; avoid direct sunlight
Other Instructions: Follow all legal requirements regarding pharmaceutical compound storage; observe proper labeling and segregation from food and beverages
Occupational Exposure Limits: No established OSHA PEL; minimize exposure through good laboratory hygiene
Engineering Controls: Use fume hood or local exhaust ventilation during handling to reduce airborne concentrations
Personal Protection Equipment: Chemical-resistant gloves (nitrile, neoprene or similar), safety goggles, laboratory coat, dust mask or respirator with particulate filter in cases of dust exposure
Hygiene Measures: Remove contaminated clothing before leaving work area; avoid prolonged skin contact; ensure hand washing after use
Appearance: White to off-white crystalline powder
Odor: Odorless or slight characteristic pharmaceutical scent
Boiling Point: Decomposes before boiling
Melting Point: Around 178–184°C (with decomposition)
Solubility: Slightly soluble in water, more readily dissolved in ethanol and chloroform
Specific Gravity: Data not widely published; considered similar to related organic solids
pH: Not applicable for solid material; weakly basic in solution
Vapor Pressure: Not relevant at typical conditions; negligible for solids
Partition Coefficient: Log Pow: approximately 6.1 (octanol-water)
Stability: Stable under normal storage and usage conditions
Chemical Stability: Stable at room temperature in tightly closed container
Conditions to Avoid: Excess heat, direct sunlight, moisture, high humidity, open flames
Incompatible Materials: Strong oxidizers, strong acids; can trigger toxic decomposition
Hazardous Decomposition Products: Nitrogen oxides, hydrogen chloride, carbon monoxide under extreme heat
Polymerization: Will not polymerize in storage or use
Likely Routes of Exposure: Skin absorption, eye contact, inhalation of powder
Acute Toxicity: LD50 (Rat, Oral): ~1600 mg/kg
Irritation/Corrosivity: Causes irritation to eyes, skin, and respiratory tract in sensitive individuals
Skin Sensitization: Some reported cases of allergic contact dermatitis in pharmacy personnel and patients
Chronic Toxicity: Liver and reproductive effects observed in animal studies at high doses; long-term human data remain inconclusive
Carcinogenicity: Not identified as carcinogen by NTP, OSHA, or IARC
Mutagenicity: No strong mutagenic findings; monitoring advised in manufacturing settings
Target Organs: Skin, liver, mucous membranes
Ecotoxicity: Exhibits toxicity to aquatic organisms such as Daphnia and fish in lab settings; environmental persistence causes concern for aquatic environments
Persistence and Degradability: Not readily biodegradable under typical environmental conditions; potential for bioaccumulation noted
Mobility in Soil: Low mobility due to poor water solubility; potential for long-term build-up in sediments
Other Adverse Effects: May disrupt aquatic ecosystems in case of large-scale spill or disposal
Waste Disposal: Dispose as hazardous pharmaceutical waste as per regional environmental regulations; products and containers must not enter general waste or water systems
Contaminated Packaging: Decontaminate before recycling or dispose of as hazardous waste
Special Precautions: Consult with licensed waste disposal contractors experienced in pharmaceutical incineration or chemical landfilling
Legal Requirements: Follow local, national, and international guidelines for medical hazardous waste
UN Number: Not regulated as dangerous goods for transport by ground, air, or sea in small quantities
Classification: Not classified as hazardous under major transport regulations such as ADR, IMDG, or IATA when shipped in typical pharmaceutical forms
Packing Group: Not applicable for this compound in packaged pharmaceuticals
Special Transport Precautions: Store away from foods and feedstuffs; keep containers tightly closed and prevent damage during transit
Regulation Status: Listed as prescription drug under Schedule H in many countries; subject to drug law enforcement and oversight
OSHA: Hazardous chemical under OSHA Hazard Communication Standard
TSCA: Listed or exempted; restrictions may apply for certain uses
SARA Title III: Not subject to reporting requirements
REACH: Substance registered or subject to notification requirement within European Economic Area
California Proposition 65: No known listing as of latest available records
Worker Protection: Training and restricted access areas required for those handling in bulk; gloves, masks, goggles advocated by workplace safety law
Labeling Requirements: Clear hazard precautionary labeling mandatory in most countries; compliance with local workplace and public safety standards
