Clotrimazole topical is an antifungal medication that fights infections caused by fungus.

Clotrimazole topical (for the skin) is used to treat skin infections such as athlete’s foot, jock itch, ringworm, and yeast infections.

Clotrimazole topical may also be used for purposes not listed in this medication guide.

Certificate of Analysis

• Description

  A white or, pale yellow crystalline powder.

  Result

  White Powder.

• Identification By IR

  The infrared absorption spectrum is concordant with the reference spectrum.

  Result

  Complies

• Identification By UV

  The UV absorption spectrum of the test sample should be concordant with standard

  Result

  Complies

• Related Substance

  NMT 0.5%

  Result

  Complies

• Sulphated Ash

  NMT 0.1%

  Result

  Complies

• Loss on Drying

  NMT 0.5%

  Result

  0.019%

• Assay

  NLT 98.0 & NMT 102.0 %

  Result

  99.51 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Clotrimazole

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Clotrimazole

  Molecular Formula

  C22H17ClN2

  Molecular Weight

  344.84 g/mol

  CAS Number

  23593-75-1

• Section 3 – HAZARDOUS IDENTIFICATION

  Classification of the substance or mixture Classification according to Regulation (EC) No 1272/2008

  Acute toxicity, Oral (Category 4), H302 Skin irritation (Category 2), H315 Eye irritation (Category 2), H319 Short-term (acute) aquatic hazard (Category 1), H400 Long-term (chronic) aquatic hazard (Category 1), H410

  Label elements

  Labelling according Regulation (EC) No 1272/2008

  Hazard statement(s)

  H302

  Harmful if swallowed.

  H315

  Causes skin irritation.

  H319

  Causes serious eye irritation.

  H410

  Very toxic to aquatic life with long lasting effects.

  Precautionary statement(s)

  P264

  Wash skin thoroughly after handling.

  P270

  Do not eat, drink or smoke when using this product.

  P273

  Avoid release to the environment.

  P301 + P312 IF SWALLOWED

  Call a POISON CENTER/ doctor if you feel unwell.

  P302 + P352 IF ON SKIN

  Wash with plenty of water.

  P305 + P351 + P338 IF IN EYES

  Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

• Section 4 – FIRST AID

  General Advice

  Show this material safety data sheet to the doctor in attendance.

  Eye Contact

  After eye contact: rinse out with plenty of water. Call in phthalmologist. Remove contact lenses.

  Skin Contact

  In case of skin contact: Take off immediately all contaminated clothing. Rinse skin with water/ shower. Consult a physician.

  Inhalation

  Fresh air. Consult doctor if feeling unwell.

  Swallowed

  Immediately make victim drink water (two glasses at most). Consult a physician.

   

  Most important symptoms and effects, both acute and delayed The most important known symptoms and effects are described in the labelling

• Section 5 – FIRE FIGHTING MEASURES

  Extinguishing Media

  Suitable Extinguishing Media

  Water Foam Carbon dioxide (CO2) Dry powder Unsuitable extinguishing media For this substance/mixture no limitations of extinguishing agents are given.

  Special hazards arising from the substance or mixture

  Carbon oxides Nitrogen oxides (NOx) Hydrogen chloride gas Combustible. Development of hazardous combustion gases or vapours possible in the event of fire.

  Advice for Fire Fighters

  Stay in danger area only with self-contained breathing apparatus. Prevent skin contact by keeping a safe distance or by wearing suitable protective clothing.

  Further Information

  Suppress (knock down) gases/vapors/mists with a water spray jet. Prevent fire extinguishing water from contaminating surface water or the ground water system

• Section 6 – ACCIDENT RELEASE MEASURES

  Personal Precautions, Protective equipment & Emergency Procedures

  Advice for non-emergency personnel: Avoid inhalation of dusts. Avoid substance contact. Ensure adequate ventilation. Evacuate the danger area, observe emergency procedures.

  Environmental Precautions

  Do not let product enter drains.

• Section 7 – HANDLING AND STORAGE

  Precaution

  For safe Handling & precautions see section 3 & 5.

  Safe Storage

  Keep container tightly closed. Store at Room Temperature.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Personal Protective Equipment

  Eye/face protection Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). Wear Safety glasses.

  Skin Protections

  Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). Wear Safety glasses.

  Body Protection

  Protective Clothing.

  Respiratory Protection

  Required when dusts are generated. Our recommendations on filtering respiratory protection are based on the following standards: DIN EN 143, DIN 14387 and other accompanying standards relating to the used respiratory protection system. Recommended Filter type: Filter type P3 The entrepeneur has to ensure that maintenance, cleaning and testing of respiratory protective devices are carried out according to the instructions of the producer. These measures have to be properly documented.

  Skin Protection

  This recommendation applies only to the product stated in the safety data sheet, supplied by us and for the designated use. When dissolving in or mixing with other substances and under conditions deviating from those stated in EN374.

  Control of environmental Exposure

  Do not let product enter drains.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Appearance

  White powder

  Odor

  None

  Melting Point

  147 – 149° C

  pH

  No data available

• Section 10 – STABILITY AND REACTIVITY

  Reactivity

  The following applies in general to flammable organic substances and mixtures: in correspondingly fine distribution, when whirled up a dust explosion potential may generally be assumed.

  Chemical Stability

  The product is chemically stable under standard ambient conditions (Room Temperature).

  Possibility of Hazardous reactions

  N/A

  Conditions to avoid

  N/A

  Incompatible Materials

  N/A

• Section 11 – TOXICOLOGICAL INFORMATION

  Skin corrosion/irritation

  Causes Skin irritation.

  Serious eye damage/eye irritation

  Causes serious Eye Irritation.

• Section 12 – ECOLOGICAL INFORMATION

  Toxicity

  No data available

  Persistence & Degradability

  No data available

  Bioaccumulative Potential

  No data available

  Mobility in soil

  No data available

• Section 13 – DISPOSAL CONSIDERATION

  Waste Treatment Methods

  No data Available

• Section 14 – TRANSPORT INFORMATION

  General Information

  Not considered hazardous when handling.

• Section 15 – REGULATORY INFORMATION

  No data Available

• Section 16 – OTHER INFORMATION

  Global Pharma provides information contained herein in good faith but makes no representation as to its comprehensives or accuracy. This document is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product.

  Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.

  GLOBAL PHARMA MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OR MERCHANTABILITY, FITNESS FOR A PARTICULER PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE PRODUCT WHICH THE INFORMATION REEFERS. GLOBAL PHARMA WILL NOT BE RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF RELIANCE UPON THIS INFORMATION.