IRIS

Manufacturer: AMERIFOODS TRADING COMPANY | NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD
Effective date: 2014-10-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:35:02

Label at a glance#

ProductIRIS

Active ingredientHYDROGEN PEROXIDE

Label structure9 sections

Indications and 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

Dosage and administration

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 or over: mix with an equal amount of water swish around in the mouth over affected area for atleast 1 minute then spit out use up to 4x daily after meals and at bedtime or as dir...

Storage and handling

keep tightly closed and in a dark place at a controlled temperature do not shake bottle hold away from face when opening

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 3%

PURPOSE

OTC - PURPOSE SECTION

first aid antiseptic/oral debriding agent

USES

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

flammable, keep away from fire and flame
will produce serious gastric disturbances if ingested

OTC - DO NOT USE 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns

OTC - STOP USE SECTION

Stop 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, seek professional or contact a Poison Control Center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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 or over:
mix with an equal amount of water
swish around in the mouth over affected area for atleast 1 minute then spit out
use up to 4x 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

STORAGE AND HANDLING SECTION

keep tightly closed and in a dark place at a controlled temperature
do not shake bottle
hold away from face when opening

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

purified water, also contains 0.001% phosphoric acid as a stabilizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel1label2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61504-033-10	2020-01-31	C162847	48780-1	9d75b9d0-91f6-f424-e053-dadaa90a57ce	88d2e9fd-8e7a-4901-8465-80c54adacc09
61504-033-12	2020-01-31	C162847	48780-1	9d75b9d0-91f6-f424-e053-dadaa90a57ce	88d2e9fd-8e7a-4901-8465-80c54adacc09
61504-033-16	2020-01-31	C162847	48780-1	9d75b9d0-91f6-f424-e053-dadaa90a57ce	88d2e9fd-8e7a-4901-8465-80c54adacc09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROGEN PEROXIDE	ACTIVE INGREDIENT	BBX060AN9V	1
HYDROGEN PEROXIDE	ACTIVE MOIETY	BBX060AN9V	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

IRIS
HYDROGEN PEROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61504-033	61504-033-16, 61504-033-10, 61504-033-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROGEN PEROXIDE	BBX060AN9V	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8a5ab2fd-3ee0-4e72-b949-2ad820a5d4f9			88d2e9fd-8e7a-4901-8465-80c54adacc09	2014-10-01	Warnings	Exact identifier spl id: 8a5ab2fd-3ee0-4e72-b949-2ad820a5d4f9 spl set id: 88d2e9fd-8e7a-4901-8465-80c54adacc09

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.