Iris 871.001/871aa

Iris 871.001/871aa
SPL v14
SPL
SPL Set ID 38b15693-7e5f-4c85-915e-9937ea018a83
Route
TOPICAL
Published
Effective Date 2026-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (30 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-09

Description

Hydrogen peroxide (stablized) 3%

Purpose

First Aid Antiseptic Oral debriding agent

Adverse Reactions

DISTRIBUTED BY: AMERIFOODS TRADING CO. P.O. BOX 512377, LOS ANGELES, CA 90051-0377 Pat. D675, 101


Medication Information

Purpose

First Aid Antiseptic

Oral debriding agent

Adverse Reactions

DISTRIBUTED BY: AMERIFOODS TRADING CO.

P.O. BOX 512377, LOS ANGELES, CA 90051-0377

Pat. D675, 101

Description

Hydrogen peroxide (stablized) 3%

Use
  • 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 assoicated with occasional sore mouth
Warnings

For external use only

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 first

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 the affected area for at least 1 minute and then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

  • children under 12 years of ago should be supervised in the use
  • children under 2 years of age: consult a dentist or doctor
Do Not Use
  • in the eyes or apply over large areas of the the body
  • longer than 1 week
Active Ingredient

Hydrogen peroxide (stablized) 3%

Other Information

keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold sprayer tip away from face when opening.

Inactive Ingredients

purified water

Principal Display Panel

61504-871-43

Iris ®

Hydrogen

Peroxide

TOPICAL SOLUTION USP

First Aid Antiseptic/Oral Debriding Agent

For Treatment of Minor Cuts & Abrasions

For use as a Gargle or Rinse

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

NET 16 FL OZ (1 PT) 473 mL

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 Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites or serious burns


Structured Label Content

Use
  • 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 assoicated with occasional sore mouth
Purpose

First Aid Antiseptic

Oral debriding agent

Warnings

For external use only

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 first

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 the affected area for at least 1 minute and then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

  • children under 12 years of ago should be supervised in the use
  • children under 2 years of age: consult a dentist or doctor
Do Not Use (Do not use)
  • in the eyes or apply over large areas of the the body
  • longer than 1 week
Active Ingredient (Active ingredient)

Hydrogen peroxide (stablized) 3%

Other Information (Other information)

keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold sprayer tip away from face when opening.

Adverse Reactions (adverse reactions)

DISTRIBUTED BY: AMERIFOODS TRADING CO.

P.O. BOX 512377, LOS ANGELES, CA 90051-0377

Pat. D675, 101

Inactive Ingredients (Inactive ingredients)

purified water

Principal Display Panel (principal display panel)

61504-871-43

Iris ®

Hydrogen

Peroxide

TOPICAL SOLUTION USP

First Aid Antiseptic/Oral Debriding Agent

For Treatment of Minor Cuts & Abrasions

For use as a Gargle or Rinse

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

NET 16 FL OZ (1 PT) 473 mL

Stop Use and Ask A Doctor If (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 Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds, animal bites or serious burns


Advanced Ingredient Data


Raw Label Data

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