SPL v1
SPL
SPL Set ID 48370aaa-da08-a2ef-e063-6394a90a62b3
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (917.62 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15

Description

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 bandalge if bandaged, let dry first Oral debriding agent adults, children over 2 years of age mix with an equal amount of water swish around in the mounth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use

Purpose

First aid antiseptic oral debriding agent

Dosage and Administration

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 bandalge if bandaged, let dry first Oral debriding agent adults, children over 2 years of age mix with an equal amount of water swish around in the mounth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use


Medication Information

Purpose

First aid antiseptic oral debriding agent

Dosage and Administration

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 bandalge

if bandaged, let dry first

Oral debriding agent

adults, children over 2 years of age

mix with an equal amount of water

swish around in the mounth over the affected area for at least 1 minute, then spit out

use up to 4 times daily after meals and at bedtime

children under 12 years of age should be supervised in the use

Description

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 bandalge if bandaged, let dry first Oral debriding agent adults, children over 2 years of age mix with an equal amount of water swish around in the mounth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use

Uses

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

Aids in the removal of the phlegm, mucus, or other secretions associated with occasional sore mouth

Section 51945-4

Active ingredient

Hydrogen peroxide (stabilized) 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 the phlegm, mucus, or other secretions associated with occasional sore mouth

Warnings

For external use only

Do not use

in the eyes or apply over large areas of the body

longer than 1 week

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 imporive in 7 days

irritation, pain or reness 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

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 bandalge

if bandaged, let dry first

Oral debriding agent

adults, children over 2 years of age

mix with an equal amount of water

swish around in the mounth over the affected area for at least 1 minute, then spit out

use up to 4 times daily after meals and at bedtime

children under 12 years of age should be supervised in the use

children under 2 years of age: consult a dentist, doctor

Other information keep tightly closed and ay controlled room temperature. Do not shake bottle

Hold away from face when opening

Inactive ingredients purified water

Warnings

For external use only

Do not use

in the eyes or apply over large areas of the body

longer than 1 week

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 imporive in 7 days

irritation, pain or reness 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

Inactive Ingredient

Inactive ingredients purified water

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Uses (USES)

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

Aids in the removal of the phlegm, mucus, or other secretions associated with occasional sore mouth

Section 51945-4 (51945-4)

Active ingredient

Hydrogen peroxide (stabilized) 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 the phlegm, mucus, or other secretions associated with occasional sore mouth

Warnings

For external use only

Do not use

in the eyes or apply over large areas of the body

longer than 1 week

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 imporive in 7 days

irritation, pain or reness 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

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 bandalge

if bandaged, let dry first

Oral debriding agent

adults, children over 2 years of age

mix with an equal amount of water

swish around in the mounth over the affected area for at least 1 minute, then spit out

use up to 4 times daily after meals and at bedtime

children under 12 years of age should be supervised in the use

children under 2 years of age: consult a dentist, doctor

Other information keep tightly closed and ay controlled room temperature. Do not shake bottle

Hold away from face when opening

Inactive ingredients purified water

Purpose (PURPOSE)

First aid antiseptic oral debriding agent

Warnings (WARNINGS)

For external use only

Do not use

in the eyes or apply over large areas of the body

longer than 1 week

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 imporive in 7 days

irritation, pain or reness 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

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients purified water

Dosage and Administration (DOSAGE AND ADMINISTRATION)

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 bandalge

if bandaged, let dry first

Oral debriding agent

adults, children over 2 years of age

mix with an equal amount of water

swish around in the mounth over the affected area for at least 1 minute, then spit out

use up to 4 times daily after meals and at bedtime

children under 12 years of age should be supervised in the use

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

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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