Hydrogen peroxide 40% topical solution is indicated for the treatment of seborrheic keratoses that are raised. The drug must be administered by a health care provider during a single in-office treatment session. The treatment session consists of 4 separate topical applications to each lesion (given approximately 1 minute apart). To prevent adverse reactions, avoid use of the solution on open or infected lesions, eyes or lesions located within the orbital rim, and lesions on mucus membrane. Health care providers are advised to wear nitrile or vinyl examination gloves when preparing and applying the solution. Hydrogen peroxide 3% topical solution and 1.8% topical gel are indicated for use as a first aid antiseptic to prevent infections in minor cuts, scrapes, and burns. In addition, the 3% solution (when mixed with an equal volume of water) may be administered as an oral swish and spit solution to clean minor wounds resulting from dental procedures, orthodontic appliances, or accidental injury.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
Oral Liquid Formulations
3% Topical Solution
-Mix the 3% hydrogen peroxide solution with an equal volume of water.
-Swish the mixture around and over the affected area(s).
-Spit out the mixture; DO NOT swallow.
Topical Administration
Other Topical Formulations
40% Topical Solution
-Must be prepared and applied by a health care provider during an in-office treatment session.
-Wear nitrile or vinyl examination gloves while activating the applicator and during the administration process.
Preparation
-While activating, hold the applicator away from the patient with the applicator cap pointing up. Do not remove the cap until after release of the solution from the ampule.
-Crush the ampule in the applicator by applying finger pressure to the diamond symbol on the applicator barrel.
-Release the sleeve from the applicator.
-While still holding the applicator with cap pointed up, tap the bottom of the applicator to separate the solution from the crush ampule.
Application
-Clean lesions to be treated using an alcohol wipe. Open or infected lesions and lesions within the orbital rim must not be treated. Avoid contact with the eyes or mucous membranes. Not for oral, ophthalmic, or intravaginal use.
-Remove the cap for the applicator.
-Gently squeeze the applicator barrel to express a drop of solution and ensure wetting of the applicator tip.
-Apply the solution directly to lesions in a circular motion. Apply enough solution to uniformly wet the lesion surface, including the edges, without excess running or dripping. Remove any excess solution from surrounding skin using a clean absorbent wipe (do not use a paper towel or tissue).
-Wait 1 minute and observe lesions; whitening of the lesions may occur. Do not progress to subsequent applications if severe erythema, edema, or pain develops.
-Administer 3 additional applications approximately 1 minute apart to each lesion (i.e., 4 total applications during 1 treatment session).
-After 1 treatment, replace the cap and discard the unit dose applicator.
3% Topical Solution and 1.8% Topical Gel
-Clean the affected area(s).
-Apply a small amount of solution or gel topically onto the affected area(s).
Dermatologic adverse reactions were observed in patients receiving treatment with hydrogen peroxide 40% topical solution during clinical trials. Application site reaction that occurred within 10 minutes of treatment included erythema (98%), stinging (93%), edema (85%), pruritus (32%), and vesiculation (18%). Other common local skin reactions that developed 1 week after treatment included scaling (72%), erythema (66%), crusting (67%), pruritus (18%), skin erosion (9%), and skin ulcer (4%). Delayed reactions (i.e., 15 weeks after the initial treatment) were also observed and included erythema (21%), skin hyperpigmentation (18%), scaling (16%), crusting (12%), and skin hypopigmentation (7%). A few patients also developed eyelid edema (0.6%) and herpes zoster infection (0.6%). Cases of crepitus have been reported during postmarketing use. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established. Instruct recipients of any hydrogen peroxide product (i.e., 3% and 40% solution or 1.8% gel) to discontinue use of the drug and seek medical attention if any of the above adverse reactions develop during treatment.
Take precautions to ensure hydrogen peroxide does not come in contact with the eyes or mucus membranes. When treating seborrheic keratoses on the face, avoid administering the solution to lesions within the orbital rim. Direct contact with the eyes can cause corneal injury (e.g., erosion, ulceration, perforation, and scarring), chemical conjunctivitis, eyelid edema, severe eye pain, or permanent eye injury, including blindness. If accidental ocular exposure occurs, flush the eye(s) with water for 15 to 30 minutes and closely monitor the patient.
To avoid accidental exposure, health care providers are advised to wear nitrile or vinyl examination gloves while activating and applying hydrogen peroxide 40% topical solution. Only apply the topical solution to seborrheic keratoses lesions that are raised; avoid use on open or infected lesions. Some drug recipients may develop a severe local skin reaction (e.g., erosion, ulceration, vesiculation, scarring). Patients who develop an adverse dermatologic reaction should not receive a second treatment course until the skin has recovered from the reaction caused by the previous treatment.
Hydrogen peroxide is not absorbed systemically after topical administration; therefore, maternal use during pregnancy is not expected to result in fetal drug exposure.
Hydrogen peroxide is not absorbed systemically by the mother following topical administration; therefore, breast-feeding is not expected to result in infant drug exposure.
For the treatment of seborrheic keratosis:
Topical dosage:
Adults: Administer 4 applications topically to raised lesions, approximately 1 minute apart, during a single in-office treatment session. Enough solution should be applied in a circular motion to wet the lesion surface, including the edges without excess running or dripping. If after approximately 3 weeks the lesions have not completely cleared, a second treatment may be administered using the same procedure (i.e., 4 topical applications administered approximately 1 minute apart).
For use as a first aid skin antisepsis to prevent infections in minor cuts, scrapes, or burns:
Topical dosage:
Adults: Apply a small amount of solution or gel topically onto the affected area(s) 1 to 3 times daily.
Children and Adolescents 2 years and older: Apply a small amount of solution or gel topically onto the affected area(s) 1 to 3 times daily.
For temporary oral wound management following minor dental procedures, orthodontic appliances, or accidental injury:
Dental dosage (oral rinse):
Adults: Swish and spit a mixture containing the 3% solution and an equal volume of water around and over the affected area(s) up to 4 times daily, or as directed by a dentist or doctor.
Children and Adolescents 2 years and older: Swish and spit a mixture containing the 3% solution and an equal volume of water around and over the affected area(s) up to 4 times daily, or as directed by a dentist or doctor.
Maximum Dosage Limits:
-Adults
4 topical applications of the 40% solution per lesion; 3 topical applications per day of the 3% solution or 1.8% gel; 4 oral swish and spit doses per day of the 3% solution.
-Geriatric
4 topical applications of the 40% solution per lesion; 3 topical applications per day of the 3% solution or 1.8% gel; 4 oral swish and spit doses per day of the 3% solution.
-Adolescents
3 topical applications per day of the 3% solution or 1.8% gel; 4 oral swish and spit doses per day of the 3% solution; 40% solution not indicated.
-Children
2 to 12 years: 3 topical applications per day of the 3% solution or 1.8% gel; 4 oral swish and spit doses per day of the 3% solution; 40% solution not indicated.
younger than 2 years: Safety and efficacy not established.
-Infants
Safety and efficacy not established.
-Neonates
Safety and efficacy not established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Hydrogen Peroxide products.
The exact mechanism by which hydrogen peroxide treats seborrheic keratoses is unknown.
Hydrogen peroxide solution is administered topically.
Affected cytochrome P450 isoenzymes and drug transporters: none
-Route-Specific Pharmacokinetics
Topical Route
Following topical application to seborrheic keratoses lesions, hydrogen peroxide rapidly dissociates into water and reactive oxygen species. An indirect assessment of reactive oxygen species did not demonstrate any systemic absorption of hydrogen peroxide.