SPL v1
SPL
SPL Set ID eb415ebb-ab41-a816-e053-2995a90abd4b
Route
TOPICAL
Published
Effective Date 2022-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (70 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-10-17

Description

Hydrogen peroxide 3%

Purpose

First aid antiseptic/oral debriding agent


Medication Information

Purpose

First aid antiseptic/oral debriding agent

Description

Hydrogen peroxide 3%

Uses

-First aid to help prevent the risk of infection in minor cuts, scraps and burns

Warning

For external use only

Directions

For use as a first aid antiseptic:

-clean affected area

-if bandaged, let dry first

-apply small amount of product on affected area 1-3 times a day

-may be covered with a sterile bandage

For use as an oral debriding agent (oral rinse)

-adults and children 2 years of age and over

-mix with and 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 bedtime or a 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

Do Not Use

-in the eyes or apply over large areas of the body

-longer than one week

Active Ingredient

Hydrogen peroxide 3%

Other Information

-keep tightly close and in a dark place at room temperature

-do not shake bottle: hold away from face when opening

Principal Display

Margrey

Hydrogen peroxide

Topical solution USP

Do not use if seal under cap

is broken or missing

32FL OZ 946ml



Distributed by BROSANT Group LLC, 15900 La cantera Parkway Suite 20255, San Antonio TX 78256, USA

Telephone: (210) 568-0444

Inactive Ingredient

Purified water

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 worsen

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away

Ask A Doctor Before Use If You Have

-deep puncture wounds, animal bites or serious burns


Structured Label Content

Uses (USES)

-First aid to help prevent the risk of infection in minor cuts, scraps and burns

Purpose

First aid antiseptic/oral debriding agent

Warning (WARNING)

For external use only

Directions (DIRECTIONS)

For use as a first aid antiseptic:

-clean affected area

-if bandaged, let dry first

-apply small amount of product on affected area 1-3 times a day

-may be covered with a sterile bandage

For use as an oral debriding agent (oral rinse)

-adults and children 2 years of age and over

-mix with and 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 bedtime or a 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

Do Not Use (DO NOT USE)

-in the eyes or apply over large areas of the body

-longer than one week

Active Ingredient (Active ingredient)

Hydrogen peroxide 3%

Other Information (OTHER INFORMATION)

-keep tightly close and in a dark place at room temperature

-do not shake bottle: hold away from face when opening

Principal Display

Margrey

Hydrogen peroxide

Topical solution USP

Do not use if seal under cap

is broken or missing

32FL OZ 946ml



Distributed by BROSANT Group LLC, 15900 La cantera Parkway Suite 20255, San Antonio TX 78256, USA

Telephone: (210) 568-0444

Inactive Ingredient (INACTIVE INGREDIENT)

Purified water

Stop Use and Ask A Doctor If (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 worsen

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away

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

-deep puncture wounds, animal bites or serious burns


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)