SODIUM PERBORATE: 49 Adverse Event Reports & Safety Profile
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Route: ORAL · Manufacturer: Vintage Brands Limited · HUMAN OTC DRUG · FDA Label: Available
First Report: 20080101 · Latest Report: 20080615
What Are the Most Common SODIUM PERBORATE Side Effects?
All SODIUM PERBORATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Condition aggravated | 49 | 100.0% | 7 | 49 |
| Therapy non-responder | 49 | 100.0% | 7 | 49 |
| Arthralgia | 48 | 98.0% | 6 | 48 |
| Arthropathy | 48 | 98.0% | 6 | 48 |
| Drug hypersensitivity | 48 | 98.0% | 6 | 48 |
| Drug ineffective | 48 | 98.0% | 6 | 48 |
| Drug intolerance | 48 | 98.0% | 6 | 48 |
| Gastrointestinal toxicity | 48 | 98.0% | 6 | 48 |
| Hepatotoxicity | 48 | 98.0% | 6 | 48 |
| Infection | 48 | 98.0% | 6 | 48 |
| Joint injury | 48 | 98.0% | 6 | 48 |
| Musculoskeletal pain | 48 | 98.0% | 6 | 48 |
| Musculoskeletal stiffness | 48 | 98.0% | 6 | 48 |
| Neoplasm malignant | 48 | 98.0% | 6 | 48 |
| Pain in extremity | 48 | 98.0% | 6 | 48 |
| Pulmonary toxicity | 48 | 98.0% | 6 | 48 |
| Therapeutic product effect incomplete | 48 | 98.0% | 6 | 48 |
| Treatment failure | 48 | 98.0% | 6 | 48 |
| Joint stiffness | 47 | 95.9% | 6 | 47 |
| Joint swelling | 47 | 95.9% | 6 | 47 |
Who Reports SODIUM PERBORATE Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 42.8 years. Most reports from: CA. View detailed demographics →
Is SODIUM PERBORATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 3 | 2 | 3 |
What Is SODIUM PERBORATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 47 |
Official FDA Label for SODIUM PERBORATE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums for temporary use to cleanse canker sores assist in the removal of foreign material from minor wounds
Dosage & Administration
Directions adults and children 6 years of age and older: dissolve one envelope in 1 ounce (30 milliliters) of warm water use immediately. swish solution around in the mouth over the affected area or gargle for at least 1 minute and then spit it out. do not swallow. use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor. children under 12 years of age should be supervised in the use of this product. consult a dentist or doctor for use in children under 6 years of age.
Warnings
Warnings For external use only. Do not use for more than 7 days unless directed by a dentist or doctor. Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days. irritation, pain, or redness persists or worsens swelling, rash, or fever develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Active Ingredient
Active ingredient (in each envelope) Sodium perborate monohydrate 1.2g Purpose Oral Debriding Agent/Oral Wound Cleanser
Inactive Ingredients
Inactive ingredients l-tartaric acid, sodium saccharin, peppermint flavor