Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c8c6609f-cc45-4bf1-aa18-22ead184cc79
Route
TOPICAL
Published
Effective Date 2010-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (3 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-07-26

Description

Active Ingredient Hydrogen peroxide 3%


Medication Information

Warnings and Precautions
Warnings

For external use only



Do not use

 
• in the eyes or apply over large areas of the body  • more than one week
Indications and Usage
Uses

first aid to help prevent 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
Directions

First aid antiseptic                                                                                                 oral debriding agent (oral rinse)

•clean affected area                                                                                               Adults and children 2 years and over

•apply a small amount of this product on the affected area 1-3 times a day                 • mix with an equal amount of water

• may be covered with a sterile bandage                                                                   • swish around in the mouth over affected area for at least 1 minute then spit out

                                                                                                                             • use up to 4  times daily after meals and at

                                                                                                                               bedtime or as suggested by a doctor or dentist

•let dry first before using bandage



for children under 2 years: consult a dentist or a doctor

children under 12 years should be supervised in the use of this product

Description

Active Ingredient Hydrogen peroxide 3%

Section 42229-5
Other information

Keep tightly closed in a dark place at a controlled room temperature

Do not shake the bottle. Keep away from face when opening
Section 50565-1
Keep out of reach of children

In case of an accidental ingestion, seek professional assistance or contact a poison control center immediately
Section 50566-9
Stop use and consult a doctor if  

• the condition persists or gets worse

• sore mouth symptoms do not improve in a week

• pain redness or irritation persists or if you develop fever ,rash or swelling
Section 50569-3
Consult a doctor before use if you have

animal bites or serious burns, deep or punctured wounds
Section 51727-6
Inactive ingredients

purified water
Section 51945-4
Package Label





Section 55105-1
Purpose

First aid antiseptic/oral debriding agent

Section 55106-9

Active Ingredient

Hydrogen peroxide 3%


Structured Label Content

Indications and Usage (34067-9)
Uses

first aid to help prevent 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 (34068-7)
Directions

First aid antiseptic                                                                                                 oral debriding agent (oral rinse)

•clean affected area                                                                                               Adults and children 2 years and over

•apply a small amount of this product on the affected area 1-3 times a day                 • mix with an equal amount of water

• may be covered with a sterile bandage                                                                   • swish around in the mouth over affected area for at least 1 minute then spit out

                                                                                                                             • use up to 4  times daily after meals and at

                                                                                                                               bedtime or as suggested by a doctor or dentist

•let dry first before using bandage



for children under 2 years: consult a dentist or a doctor

children under 12 years should be supervised in the use of this product

Warnings and Precautions (34071-1)
Warnings

For external use only



Do not use

 
• in the eyes or apply over large areas of the body  • more than one week
Section 42229-5 (42229-5)
Other information

Keep tightly closed in a dark place at a controlled room temperature

Do not shake the bottle. Keep away from face when opening
Section 50565-1 (50565-1)
Keep out of reach of children

In case of an accidental ingestion, seek professional assistance or contact a poison control center immediately
Section 50566-9 (50566-9)
Stop use and consult a doctor if  

• the condition persists or gets worse

• sore mouth symptoms do not improve in a week

• pain redness or irritation persists or if you develop fever ,rash or swelling
Section 50569-3 (50569-3)
Consult a doctor before use if you have

animal bites or serious burns, deep or punctured wounds
Section 51727-6 (51727-6)
Inactive ingredients

purified water
Section 51945-4 (51945-4)
Package Label





Section 55105-1 (55105-1)
Purpose

First aid antiseptic/oral debriding agent

Section 55106-9 (55106-9)

Active Ingredient

Hydrogen peroxide 3%


Advanced Ingredient Data


Raw Label Data

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