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Cool Side Effects submitted to FDA

Total Cool reports: 22.
Cool FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Cool Side Effects: stomach discomfort, skin discolouration, oral pain, open wound, odynophagia, lip exfoliation, lip dry, dry throat, cheilitis, burning sensation, anaphylactic reaction,
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Cool Side Effects Report #5663804-3
Consumer or non-health professional from BRAZIL reported COOL problem on Feb 28, 2008. Male patient, child 2 years of age, weighting 28.66 lb, was diagnosed with accidental exposure, pyrexia and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: accidental exposure, convulsion, pyrexia, stomatitis. COOL dosage: unknown. During the same period patient was treated with DIPYRONE. Patient recovered.



Cool Side Effects Report #5668094-3
COOL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 04, 2008. Male patient was diagnosed with pharyngolaryngeal pain and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: blister, pharyngolaryngeal pain. COOL dosage: unknown. Patient recovered.



Cool Side Effects Report #5668095-5
Consumer or non-health professional from UNITED STATES reported COOL problem on Mar 04, 2008. Male patient, child 12 years of age, weighting 150.0 lb, was treated with COOL. After drug was administered, patient experienced the following problems/side effects: accidental exposure, eye irritation, eye swelling, vision blurred. COOL dosage: unknown. Patient recovered.



Cool Side Effects Report #5668191-2
COOL problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Mar 03, 2008. Male patient, 62 years of age, was treated with COOL. After drug was administered, patient experienced the following problems/side effects: accidental exposure, chest pain. COOL dosage: unknown. Patient recovered.




Cool Side Effects Report #5682822-2
Consumer or non-health professional from UNITED STATES reported COOL problem on Mar 12, 2008. Female patient, 40 years of age, weighting 160.0 lb, was diagnosed with dental disorder prophylaxis and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: dyspepsia, gastritis, oesophagitis, sensitivity of teeth. COOL dosage: unknown. During the same period patient was treated with VITAMIN. Patient was hospitalized. Patient recovered.



Cool Side Effects Report #5682894-5
COOL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 18, 2008. Female patient, 60 years of age, weighting 155.0 lb, was diagnosed with nasopharyngitis and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: oral discomfort, skin exfoliation. COOL dosage: unknown. Patient recovered.



Cool Side Effects Report #5632901-0
Consumer or non-health professional from DENMARK reported COOL problem on Feb 01, 2008. Female patient was treated with COOL. After drug was administered, patient experienced the following problems/side effects: burning sensation mucosal, hypoaesthesia, oral disorder, oral pain. COOL dosage: unknown. Patient recovered.



Cool Side Effects Report #5564155-8
COOL problem was reported by a Consumer or non-health professional from BRAZIL on Dec 04, 2007. Male patient, 26 years of age, weighting 180.8 lb, was diagnosed with dental disorder prophylaxis and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: aphthous stomatitis, oral disorder, oral pain, speech disorder. COOL dosage: 10 ML BID (10 ML), ORAL. Patient recovered.



Cool Side Effects Report #5510787-2
Consumer or non-health professional from UNITED STATES reported COOL problem on Oct 31, 2007. Male patient, 82 years of age, weighting 158.0 lb, was diagnosed with dental disorder prophylaxis and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: accidental exposure, blood pressure increased. COOL dosage: unknown. Patient recovered.




Cool Side Effects Report #5525483-5
COOL problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 13, 2007. Male patient, 27 years of age, weighting 180.0 lb, was treated with COOL. After drug was administered, patient experienced the following problems/side effects: alcohol use, incorrect dose administered. COOL dosage: unknown. During the same period patient was treated with ALCOHOL. Patient recovered.



Cool Side Effects Report #5527515-7
Consumer or non-health professional from UNITED STATES reported COOL problem on Nov 13, 2007. Male patient, child 7 years of age, weighting 50.00 lb, was treated with COOL. After drug was administered, patient experienced the following problems/side effects: accidental exposure, crying, eye burns, pain, screaming. COOL dosage: unknown. During the same period patient was treated with CLARITIN, SINGULAIR. Patient recovered.



Cool Side Effects Report #5444506-5
COOL problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 21, 2007. Female patient, 80 years of age, weighting 120.0 lb, was diagnosed with poisoning and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: stomach discomfort. COOL dosage: unknown. During the same period patient was treated with KLONOPIN. Patient recovered.



Cool Side Effects Report #5794107-4
Consumer or non-health professional from UNITED STATES reported COOL problem on June 18, 2008. Female patient was treated with COOL. After drug was administered, patient experienced the following problems/side effects: application site burn, glossodynia, tongue ulceration. COOL dosage: unknown. Patient recovered.



Cool Side Effects Report #5729849-X
COOL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 22, 2008. Female patient, weighting 162.0 lb, was diagnosed with dental disorder prophylaxis and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: abdominal pain, gastritis, glossodynia, musculoskeletal chest pain, nausea, oesophagitis, oral discomfort, sensitivity of teeth, tongue disorder. COOL dosage: unknown. During the same period patient was treated with VITAMIN. Patient was hospitalized. Patient recovered.




Cool Side Effects Report #5729855-5
Consumer or non-health professional from UNITED STATES reported COOL problem on Apr 24, 2008. Female patient, child 7 years of age, weighting 56.00 lb, was treated with COOL. After drug was administered, patient experienced the following problems/side effects: accidental exposure, crying, eye irritation, ocular hyperaemia. COOL dosage: unknown. Patient recovered.



Cool Side Effects Report #5731322-X
COOL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 29, 2008. Male patient was diagnosed with dental disorder prophylaxis and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: oral discomfort, oral pain, oropharyngeal blistering, skin exfoliation. COOL dosage: unknown. During the same period patient was treated with LIPITOR. Patient recovered.



Cool Side Effects Report #5735948-9
Consumer or non-health professional from UNITED STATES reported COOL problem on Apr 28, 2008. Female patient, 65 years of age, weighting 150.0 lb, was diagnosed with dental disorder prophylaxis and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: rash. COOL dosage: unknown. Patient recovered.



Cool Side Effects Report #5738360-1
COOL problem was reported by a Consumer or non-health professional from UNITED STATES on May 06, 2008. Female patient, 60 years of age, weighting 155.0 lb, was diagnosed with nasopharyngitis and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: oral discomfort, oral mucosal exfoliation. COOL dosage: unknown. Patient recovered.



Cool Side Effects Report #5748690-5
Consumer or non-health professional from AUSTRALIA reported COOL problem on May 12, 2008. Male patient was diagnosed with breath odour and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: ageusia, glossodynia, oral discomfort, oropharyngeal blistering, tongue blistering. COOL dosage: unknown. Patient recovered.




Cool Side Effects Report #5723891-0
COOL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 16, 2008. Male patient, child 12 years of age, was treated with COOL. After drug was administered, patient experienced the following problems/side effects: disorientation. COOL dosage: unknown. During the same period patient was treated with ANTIEPILEPTICS. Patient recovered.



Cool Side Effects Report #5728794-3
Consumer or non-health professional from UNITED KINGDOM reported COOL problem on Apr 17, 2008. Female patient was treated with COOL. After drug was administered, patient experienced the following problems/side effects: caustic injury, feeling abnormal, oral disorder, tongue disorder. COOL dosage: unknown. Patient recovered.



Cool Side Effects Report #5302888-9
COOL problem was reported by a Physician from UNITED STATES on Apr 19, 2007. Female patient, weighting 65.00 lb, was diagnosed with dental disorder prophylaxis and was treated with COOL. After drug was administered, patient experienced the following problems/side effects: facial palsy. COOL dosage: unknown. Patient recovered.




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, Cool was diagnosed with accidental exposure, pyrexia and Cool was diagnosed with pharyngolaryngeal pain and