Active Ingredient
Active ingredient (by volume)
Hydrogen peroxide 3%
Pharmacys Prescription Hydrogen Peroxide
FDA Label NDC 72197-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Consumer Products Corp for the product Pharmacys Prescription Hydrogen Peroxide (NDC 72197-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, warnings, stop use, keep out of reach of children, directions, inactive ingredients, indications & usage section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First aid antiseptic/oral debriding agent.
Warnings
Warnings
For external use only.
Stop Use
Stop use and ask a doctor if: the condition persists or gets worse, sore mouth symptoms do not improve within 7 days, irritation, pain or redness persists or worsens, swelling, rash or fever develops.
Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. If swallowed, seek professional or contact a Poison Control Center immediately.
Directions
Directions
First aid antiseptic:
Clean affected area; apply small amount of product on affected area 1-3 times a day; may be covered with a sterile bandage; if bandage, let dry first.
Oral debriding agent (oral rinse):
Adults and children 2 years of age and over:
Mix with an equal amount of water; swish around in the mouth over affected area for at least 1 minute and then spit out; use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
Inactive Ingredients
Inactive ingredient
Purified water, also contains 0.001% Phosphoric acid as a stabilizer.
Indications & Usage Section
Do not use
In the eyes or apply over large areas of the body; longer than one week; on deep or puncture wounds, animal bites, or on serious burns.
Package Label.Principal Display Panel
Hydrogen Peroxide 01 (Hydrogen Peroxide 01)
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