Hydrogen Peroxide — v5

Hydrogen Peroxide

3 Views

Version

v5

Effective date

September 29, 2025

Original packager

Yes

Sections captured

14

Identifiers

Document ID
841df9a5-fe38-4863-9198-3abc8d5e1071
Set ID
9db73da2-5b70-41e6-bcf9-caa7f1142024
Application numbers
M022
Product NDCs
55319-567
Package NDCs
55319-567-16, 55319-567-32
Original packager NDCs

Names & Manufacturers

Brand names
Hydrogen Peroxide
Generic names
HYDROGEN PEROXIDE
Manufacturer names
Family Dollar (FAMILY WELLNESS)
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
HYDROGEN PEROXIDE
Routes
TOPICAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
BBX060AN9V
UPC
0032251920653

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Hydrogen peroxide 3%
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns
Do Not Use (1)

Sequence 1

Do not use in the eyes or apply over large areas of the body longer than one week
Dosage And Administration (1)

Sequence 1

Directions For use as a 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 bandaged, let dry first For use as an 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. 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 doctor or dentist
Inactive Ingredient (1)

Sequence 1

Inactive ingredient purified water
Indications And Usage (1)

Sequence 1

Uses first aid to help prevent the risk of infection in minor cuts, scrapes, and burns aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Package Label Principal Display Panel (2)

Sequence 1

Principal Display Panel HYDROGEN PEROXIDE 3% USP TOPICAL SOLUTION 3% USP First Aid Antiseptic Oral Debriding Agent (Oral Rinse) For treatment of minor cuts, scrapes, and burns For use as a gargle or rinse TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. FL OZ (mL) DISTRIBUTED BY: MIDWOOD BRANDS, LLC 510 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Sequence 2

Package Label Family Wellness Hydrogen Peroxide Topical Solution Hydrogen peroxide 3%
Purpose (1)

Sequence 1

Purpose first aid antiseptic/oral debriding agent
Questions (1)

Sequence 1

Questions or comments? Call 1 -877-753-3935 Monday-Friday 9AM-5PM EST
Spl Product Data Elements (1)

Sequence 1

Hydrogen Peroxide Hydrogen Peroxide HYDROGEN PEROXIDE HYDROGEN PEROXIDE WATER
Spl Unclassified Section (1)

Sequence 1

Other information keep tightly closed and in a dark place at room temperature do not shake bottle. Hold away from face when opening.
Stop Use (1)

Sequence 1

Stop use and ask a doctor if swelling, rash, or fever develops the condition persists or gets worse sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens
Warnings (1)

Sequence 1

Warnings For external use only. Do not use in the eyes or apply over large areas of the body longer than one week Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns Stop use and ask a doctor if swelling, rash, or fever develops the condition persists or gets worse sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

OpenFDA raw payload

{'application_number': ['M022'],
 'brand_name': ['Hydrogen Peroxide'],
 'generic_name': ['HYDROGEN PEROXIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Family Dollar (FAMILY WELLNESS)'],
 'package_ndc': ['55319-567-32', '55319-567-16'],
 'product_ndc': ['55319-567'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['841df9a5-fe38-4863-9198-3abc8d5e1071'],
 'spl_set_id': ['9db73da2-5b70-41e6-bcf9-caa7f1142024'],
 'substance_name': ['HYDROGEN PEROXIDE'],
 'unii': ['BBX060AN9V'],
 'upc': ['0032251920653']}