HYDROGEN PEROXIDE: 434 Adverse Event Reports & Safety Profile
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Route: TOPICAL · Manufacturer: Meijer, Inc. · FDA Application: 209305 · HUMAN OTC DRUG · FDA Label: Available
Patent Expires: Jul 4, 2035 · First Report: 20050101 · Latest Report: 20250330
What Are the Most Common HYDROGEN PEROXIDE Side Effects?
All HYDROGEN PEROXIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 69 | 15.9% | 0 | 10 |
| Application site discolouration | 51 | 11.8% | 0 | 1 |
| Application site erythema | 37 | 8.5% | 0 | 0 |
| Product complaint | 36 | 8.3% | 0 | 0 |
| Application site pain | 28 | 6.5% | 0 | 0 |
| Tooth fracture | 23 | 5.3% | 0 | 0 |
| Tooth loss | 19 | 4.4% | 0 | 0 |
| Pain | 17 | 3.9% | 0 | 1 |
| Tooth injury | 17 | 3.9% | 0 | 0 |
| Toothache | 17 | 3.9% | 0 | 0 |
| Scab | 16 | 3.7% | 0 | 0 |
| Swelling of eyelid | 16 | 3.7% | 0 | 0 |
| Application site scar | 15 | 3.5% | 0 | 0 |
| Erythema | 15 | 3.5% | 0 | 0 |
| Scar | 15 | 3.5% | 0 | 0 |
| Accidental exposure to product | 14 | 3.2% | 2 | 4 |
| Tooth discolouration | 14 | 3.2% | 0 | 0 |
| Application site scab | 13 | 3.0% | 0 | 0 |
| Gastritis erosive | 13 | 3.0% | 0 | 12 |
| Gingival discomfort | 13 | 3.0% | 0 | 0 |
Who Reports HYDROGEN PEROXIDE Side Effects? Age & Gender Data
Gender: 70.7% female, 29.3% male. Average age: 54.0 years. Most reports from: US. View detailed demographics →
Is HYDROGEN PEROXIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 1 | 0 | 1 |
| 2013 | 1 | 0 | 1 |
| 2014 | 11 | 0 | 1 |
| 2015 | 12 | 0 | 4 |
| 2016 | 17 | 0 | 2 |
| 2017 | 21 | 0 | 5 |
| 2018 | 86 | 4 | 4 |
| 2019 | 51 | 0 | 4 |
| 2020 | 3 | 1 | 1 |
| 2021 | 9 | 2 | 1 |
| 2022 | 3 | 0 | 0 |
| 2023 | 3 | 0 | 0 |
| 2024 | 1 | 0 | 0 |
| 2025 | 1 | 0 | 0 |
What Is HYDROGEN PEROXIDE Used For?
| Indication | Reports |
|---|---|
| Seborrhoeic keratosis | 159 |
| Product used for unknown indication | 76 |
| Dental cosmetic procedure | 18 |
| Skin lesion | 14 |
| Tooth discolouration | 7 |
| Dental care | 6 |
| Dental disorder prophylaxis | 6 |
| Covid-19 | 5 |
HYDROGEN PEROXIDE vs Alternatives: Which Is Safer?
Official FDA Label for HYDROGEN PEROXIDE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses
- first aid to help protect against bacterial contamination in minor oral wounds
- for temporary pain relief and
- temporary use in cleansing minor wounds or minor gum inflammation resulting from:
- minor dental procedures
- dentures
- orthodontic appliances
- accidental injury
- other irritations of the mouth and gums
- canker sores
- aids in the removal of:
- phlegm
- mucus
- other secretions associated with occasional sore mouth
Dosage & Administration
Directions
- Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the affected area for at least 1 minute, then spit out.
- Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician.
- Children under 12 years of age should be supervised in the use of the product.
- Children under 2 years of age: Consult a dentist or physician.
Directions
- Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the affected area for at least 1 minute, then spit out.
- Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician.
- Children under 12 years of age should be supervised in the use of the product.
- Children under 2 years of age: Consult a dentist or physician.
Known Adverse Reactions
ADVERSE REACTION SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION Walgreens Pharmacist Recommended Our Pharmacists recommend the Walgreens brand. We invite you to compare to national brands. ††This product is not manufactured or distributed by Colgate-Palmolive Company, owner of the registered trademarks Colgate ® and Peroxyl ® . DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com 1-800-925-4733 ©2021 WALGREEN CO. MADE IN U.S.A WITH U.S. AND FOREIGN COMPONENTS
Warnings
Warnings For external use only Do not use in the eyes or apply over large area of the body Longer 1 week Ask doctor before use if you have deep or puncture wounds, animal bites or serious burns. Stop use and ask a doctor if the condition persist or gets worse Sore mouth symptoms do not improve in 7 days irritation, pain, or redness persist or worsen swelling, rash or Fever develops Keep out of reach of children :If swallowed ,get medical help or contact a Poison Control Center right away . Children under 12 years of age should be supervised in the use of this product Children under 2 year of age : consult a dentist or doctor.
Active Ingredient
Active ingredients Purpose Hydrogen peroxide 1.5% Oral debriding agent/Oral antiseptic Menthol 0.1% Oral pain reliever
Inactive Ingredients
Inactive ingredients Glycerin, PEG-32, Xanthan gum, Citric Acid, Sodium Citrate, Disodium Pyrophosphate, Sodium metaphosphate, Disodium EDTA, Stevioside, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Eucalyptus Globulus Leaf Extract, Salvia Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Chaenomeles Sinensis Fruit Extract, Leontopodium Alpinum Extract, Menthol, Mentha Pulegium Oil, Peach Mint Flavor, Honey Peach Flavor, Poloxamer 407, Sodium Lauryl Sulfate, Water