IRIS- hydrogen peroxide liquid

IRIS by

Drug Labeling and Warnings

IRIS by is a Otc medication manufactured, distributed, or labeled by AMERIFOODS TRADING COMPANY, NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Hydrogen Peroxide 3%

PURPOSE

first aid antiseptic/oral debriding agent

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

Warnings

For external use only.

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

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

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

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

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

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 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

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IRIS 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61504-033
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 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	97 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61504-033-16	473 g in 1 BOTTLE, PLASTIC
2	NDC: 61504-033-10	296 g in 1 BOTTLE, SPRAY
3	NDC: 61504-033-12	3785 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2014

Labeler - AMERIFOODS TRADING COMPANY (626388680)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD		530766098	manufacture(61504-033)