Dexamethasone Oral Solution USP Intensol (Concentrate) 1 mg/mL

Hikma Pharmaceuticals USA Inc

Revision date : 2021-11-08

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GHS02 GHS08
Health risk rating 5
Safety risk rating 2
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

15-40

EC/CAS

57-55-6

Name of the chemical

1,2-propanediol

Concentration

15-40

EC/CAS

64-17-5

Name of the chemical

Ethanol

Concentration

15-40

EC/CAS

65-85-0

Name of the chemical

Benzoic acid

Concentration

≤0.1

EC/CAS

77-92-9

Name of the chemical

Citric acid

Concentration

≤0.1

General Information

Version

1.0

Revision date

2021-11-08

Product name

Dexamethasone Oral Solution USP Intensol (Concentrate) 1 mg/mL

1.2.1 Relevant identified uses

Prescription medication. See Package Insert for more information

Emergency telephone

1.800.424.9300

Icons in SDS

GHS02 GHS08 M004 M009 M010 M017 T013

Company Information

company name

Hikma Pharmaceuticals USA Inc

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H226, H317, H319, H334, H360

Hazard statements

Code

Statements

H226

Flammable liquid and vapour

Section 2

SECTION 2: Hazards identification

This is a pharmaceutical product designed to be prescribed by a licensed health care professional. Should any person while using this product observe any adverse health effects, they should seek medical treatment. Classification of the Substance or Mixture Flam. Liq. 3 H226 Eye Irrit. 2 H319 Resp. Sens. 1 H334 Skin Sens. 1 H317 Repr. 1B H360

Hazard statements

see section 16 : H226 - Flammable liquid and vapor. H317 - May cause an allergic skin reaction. H319 - Causes serious eye irritation. H334 - May cause an allergy or asthma symptoms or breathing difficulties if inhaled. H360 - May damage fertility or the unborn child.

2.2 Label elements

GHS-US Labeling

Hazard pictograms

GHS02 GHS08

Signal word

Danger

Precautionary statements

P201 - Obtain special instructions before use. P202 - Do not handle until all safety precautions have been read and understood. P210 - Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233 - Keep container tightly closed. P240 - Ground/Bond container and receiving equipment. P241 - Use explosion-proof electrical, ventilating, and lighting equipment. P242 - Use only non-sparking tools. P243 - Take precautionary measures against static discharge. P261 - Avoid breathing vapors, mist, or spray. P264 - Wash hands, forearms, and other exposed areas thoroughly after handling. P272 - Contaminated work clothing must not be allowed out of the workplace. P280 - Wear protective gloves, protective clothing, and eye protection. P284 - [In case of inadequate ventilation] wear respiratory protection. P303+P361+P353 - If on skin (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. P304+P341 - If inhaled: If breathing is difficult, remove person to fresh air and keep comfortable for breathing. P305+P351+P338 - If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P308+P313 - If exposed or concerned: Get medical advice/attention. P321 - Specific treatment (see section 4 on this SDS). P333+P313 - If skin irritation or rash occurs: Get medical advice/attention. P337+P313 - If eye irritation persists: Get medical advice/attention. P342+P311 - If experiencing respiratory symptoms: Call a poison center or doctor. P363 - Wash contaminated clothing before reuse. P370+P378 - In case of fire: Use appropriate media (see section 5) to extinguish. P403+P235 - Store in a well-ventilated place. Keep cool. P405 - Store locked up. P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations.

Other hazards

Exposure may aggravate pre-existing eye, skin, or respiratory conditions

Ingredient(s) with unknown acute toxicity

No data available

2.1 Classification of the substance or mixture

Flam. Liq. 3 H226 Eye Irrit. 2 H319 Resp. Sens. 1 H334 Skin Sens. 1 H317 Repr. 1B H360 Full text of hazard classes and H-statements : see section 16

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