Hydrogen Peroxide Topical Solution Usp 3%

Hydrogen Peroxide Topical Solution Usp 3%
SPL v2
SPL
SPL Set ID 091bea0c-7582-45d7-b04e-7d49d7fc4648
Route
TOPICAL
Published
Effective Date 2020-10-22
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 2015-11-25

Description

Hydrogen peroxide 3%

Purpose

First aid antiseptic/oral debriding agent


Medication Information

Purpose

First aid antiseptic/oral debriding agent

Dosage and Administration

Directions  For use a 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

For use as an 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 affected area for at least 1 minute and then spit out. Do not swallow.

use up to 4 times 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 doctor or dentist

Description

Hydrogen peroxide 3%

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

Section 42229-5

Topical Solution USP 3%

First Aid Antiseptic/Oral Debriding Agent

For Treatment of Minor Cuts & Abrasions

For Use As a Gargle or Rinse

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

Distributed by:

Universal Distribution Center

96 Distribution Boulevard

Edison, NJ 08817

Made in India

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings

For external use only.

Do not use  in the eyes or apply over large areas of the body longer than one week

Ask a doctor before use if you have  deep 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

Packaging

Drug Facts

Active Ingredient

Hydrogen peroxide 3%

Other Information

Keep tightly closed and in a dark place at room temperature. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

purified water


Structured Label Content

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

Dosage and Administration (34068-7)

Directions  For use a 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

For use as an 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 affected area for at least 1 minute and then spit out. Do not swallow.

use up to 4 times 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 doctor or dentist

Section 42229-5 (42229-5)

Topical Solution USP 3%

First Aid Antiseptic/Oral Debriding Agent

For Treatment of Minor Cuts & Abrasions

For Use As a Gargle or Rinse

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

Distributed by:

Universal Distribution Center

96 Distribution Boulevard

Edison, NJ 08817

Made in India

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Purpose

First aid antiseptic/oral debriding agent

Warnings

For external use only.

Do not use  in the eyes or apply over large areas of the body longer than one week

Ask a doctor before use if you have  deep 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

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Hydrogen peroxide 3%

Other Information (Other information)

Keep tightly closed and in a dark place at room temperature. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient (Inactive ingredient)

purified water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)