Label: 3% HYDROGEN PEROXIDE- hydrogen peroxide solution
- NDC Code(s): 52000-433-16, 52000-433-32
- Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
When using this product • do not get into eyes • do not apply over large areas of the body • do not use longer than one week unless directed by a doctor
Ask a doctor before use if you have
• deep or puncture wounds, animal bites, or serious burnsStop use and ask a doctor if • the condition persists or gets worse • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens • swelling, rash, or fever develops
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Directions
First aid antiseptic:
• clean the affected area • apply a small amount of product on the affected area 1 to 3 times a day • may be covered with a sterile bandage • if bandaged, let dry firstFor use as an oral debriding agent (oral rinse)
• adults and children over 2 years of age:
• mix with an equal amount of water
• swish around in the mouth over affected area for at least 1 minute and then spit 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 should be supervised in the use of this product
• children under 2 years of age: consult a dentist or doctor - Other information
- Inactive ingredient
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SPL UNCLASSIFIED SECTION
For the Treatment of Minor Cuts and Abrasions
For Use as a Gargle or Rinse
TAMPER EVIDENT: DO NOT USE IF THE PRINTED SAFETY SEAL AROUND OR UNDER THE CAP IS BROKEN OR MISSING.
Mfd for and Distributed by:
Universal Distribution Center LLC
330 Applegarth Road, Monroe Township,
NJ 08831www.universaldc.com
“U” is a Registered Trademark of
Universal Distribution Center, LLCMade in Turkey
- Packaging
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INGREDIENTS AND APPEARANCE
3% HYDROGEN PEROXIDE
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-433 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 3 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-433-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/08/2025 2 NDC:52000-433-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/08/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M003 12/08/2025 Labeler - Universal Distribution Center LLC (019180459)

