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IRIS by AMERIFOODS TRADING COMPANY

Medically reviewed on Oct 1, 2018

Dosage form: liquid
Ingredients: HYDROGEN PEROXIDE 3g in 100g
Labeler: AMERIFOODS TRADING COMPANY
NDC Code: 61504-033

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

IRIS 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61504-033
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER97 g  in 100 g
Packaging
#Item CodePackage Description
1NDC:61504-033-16473 g in 1 BOTTLE, PLASTIC
2NDC:61504-033-10296 g in 1 BOTTLE, SPRAY
3NDC:61504-033-123785 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2014
Labeler - AMERIFOODS TRADING COMPANY (626388680)
Establishment
NameAddressID/FEIOperations
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD530766098manufacture(61504-033)

 
AMERIFOODS TRADING COMPANY

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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