Peroxyl Mouth Sore Mild Mint

Manufacturer: Colgate Oral Pharmaceuticals Inc. | COLGATE PALMOLIVE COMPANY
Effective date: 2024-11-25
Label type: HUMAN OTC DRUG LABEL
Version: 18
Source: full-release
Hydrated at: 2026-06-01 00:39:24

Label at a glance#

ProductPeroxyl Mouth Sore Mild Mint

Active ingredientHYDROGEN PEROXIDE

Label structure12 sections

Indications and uses

for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums

Dosage and administration

Adults and children 2 years of age and older: rinse half a capful (two teaspoons or 10 mL) 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 directed by a dentist or physician Children under 12 years of age should be supervised in the use of the product Children under 2 years of age: consult a dentist or physician

Storage and handling

store at controlled room temperature 68 – 77° F (20 – 25°C)

Contacts and useful links#

PhoneLabel contact1-800-468-6502

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 1.5% (w/v)

Purposes

OTC - PURPOSE SECTION

Oral debriding agent/oral wound cleanser

Uses

INDICATIONS & USAGE SECTION

for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use this product for more than 7 days unless directed by a dentist or physician.

OTC - WHEN USING SECTION

When using this product, do not swallow.

Stop use and ask a doctor if

OTC - STOP USE SECTION

sore mouth symptoms do not improve within 7 days
irritation, pain or redness persists or worsens
swelling, rash or fever develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: rinse half a capful (two teaspoons or 10 mL) 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 directed by a dentist or physician
Children under 12 years of age should be supervised in the use of the product
Children under 2 years of age: consult a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, FD&C blue no. 1

Other Information

STORAGE AND HANDLING SECTION

store at controlled room temperature 68 – 77° F (20 – 25°C)

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE*

Colgate^®
Oral Debriding Agent

Peroxyl^®

Mouth Sore Rinse |
1.5% Hydrogen
Peroxide

CLEANSES & PROMOTES HEALING
OF MINOR ORAL WOUNDS

HELPS PROMOTE HEALING OF:

ORAL SORES
IRRITATIONS
MOUTH BURNS

MILD MINT

16.9 FL OZ
(1.05 PT)
500 mL

Helps Promote Healing

P9933376

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 50 Dose Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate^®

Peroxyl^®

MOUTH SORE
RINSE
ALCOHOL-FREE
1.5% Hydrogen Peroxide

MILD MINT

50 Unit Dose Packets 0.34 FL OZ (10 mL) Each
TOTAL 17 FL OZ (1.06 PT) 502 mL

PRINCIPAL DISPLAY PANEL - 50 Dose Packet Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
358975	hydrogen peroxide 1.5 % Mouthwash	PSN	18
1727009	Peroxyl 1.5 % Mouthwash	PSN	18
1727009	hydrogen peroxide 15 MG/ML Mouthwash [Peroxyl]	SBD	18
358975	hydrogen peroxide 15 MG/ML Mouthwash	SCD	18
358975	hydrogen peroxide 1.5 % Mouthwash	SY	18
1727009	Peroxyl 1.5 % Mouthwash	SY	18
1727009	Peroxyl 15 MG/ML Mouthwash	SY	18

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0126-0083-16	Peroxyl Mouth Sore Mild Mint	500 mL in 1 BOTTLE, PLASTIC	RINSE	500	18
0126-0083-22	Peroxyl Mouth Sore Mild Mint	1000 mL in 1 BOTTLE	RINSE	1000	18
0126-0083-31	Peroxyl Mouth Sore Mild Mint	946 mL in 1 BOTTLE	RINSE	946	18
0126-0083-70	Peroxyl Mouth Sore Mild Mint	10 mL in 1 POUCH	RINSE	10	18
0126-0083-70	Peroxyl Mouth Sore Mild Mint	50 in 1 CARTON	RINSE	50	18
0126-0083-99	Peroxyl Mouth Sore Mild Mint	250 mL in 1 BOTTLE, PLASTIC	RINSE	250	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0126-0083	PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS INC.]	18	Current NDC, Legacy NDC, 6 package rows	20241127_b1e1b7c9-dea7-4d64-b6a8-5343f4176359.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Hydrogen Peroxide	ACTIVE INGREDIENT	BBX060AN9V	1
Hydrogen Peroxide	ACTIVE MOIETY	BBX060AN9V	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
Poloxamer 338	INACTIVE INGREDIENT	F75JV2T505	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

Peroxyl Mouth Sore Mild Mint
Hydrogen Peroxide
WATER
SORBITOL
PROPYLENE GLYCOL
POLOXAMER 338
POLYSORBATE 20
SACCHARIN SODIUM
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0126-0083	0126-0083-16, 0126-0083-99, 0126-0083-70, 0126-0083-31, 0126-0083-22

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROGEN PEROXIDE	BBX060AN9V	ACTIB
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POLOXAMER 338	F75JV2T505	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 216 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / BUCCAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / BUCCAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TAMPON / VAGINAL	64.8 mg		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAMUSCULAR	1.62 %w/v		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SOLUTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / BUCCAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, FILM COATED / ORAL	0.35 mg		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAMUSCULAR	1.62 %w/v		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, FILM COATED / ORAL	0.35 mg		Exact identifier — unii candidate 168 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii+route 6 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 168 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii+route 18 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii+route 18 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / BUCCAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET / ORAL		17 mg	Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 168 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii+route 18 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TAMPON / VAGINAL	64.8 mg		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, FILM COATED / ORAL	0.35 mg		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii+route 18 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii+route 12 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SPRAY, METERED / NASAL		40 mg	Exact identifier — unii candidate 168 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii+route 12 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 168 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 168 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / BUCCAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Peroxyl Mouth Sore Mild Mint	HYDROGEN PEROXIDE	Colgate Oral Pharmaceuticals Inc.	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	2024-11-25	Warnings	Exact identifier ndc (package): 0126-0083-22 ndc (package): 0126-0083-31 ndc (package): 0126-0083-99 ndc (package): 0126-0083-16 ndc (package): 0126-0083-70 ndc (product): 0126-0083 ndc11 (package): 00126008331 ndc11 (package): 00126008399 ndc11 (package): 00126008322 ndc11 (package): 00126008316 ndc11 (package): 00126008370 spl id: 0df671b6-d668-41ee-935d-838a62924b58 spl set id: b1e1b7c9-dea7-4d64-b6a8-5343f4176359

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.