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NDC 00126-0083-16 Peroxyl Mouth Sore Mild Mint 15 mg/mL Details

Peroxyl Mouth Sore Mild Mint 15 mg/mL

Peroxyl Mouth Sore Mild Mint is a BUCCAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by Colgate Oral Pharmaceuticals, Inc.. The primary component is HYDROGEN PEROXIDE.

Product Information

NDC	00126-0083
Product ID	0126-0083_56331d75-a18b-434d-a26c-0ee9cf160d55
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Peroxyl Mouth Sore Mild Mint
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hydrogen Peroxide
Product Type	HUMAN OTC DRUG
Dosage Form	RINSE
Route	BUCCAL
Active Ingredient Strength	15
Active Ingredient Units	mg/mL
Substance Name	HYDROGEN PEROXIDE
Labeler Name	Colgate Oral Pharmaceuticals, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00126-0083-16 (00126008316)

Pricing Information	N/A
NDC Package Code	0126-0083-16
Billing NDC	00126008316
Package	500 mL in 1 BOTTLE, PLASTIC (0126-0083-16)
Marketing Start Date	2009-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b1e1b7c9-dea7-4d64-b6a8-5343f4176359 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrogen peroxide 1.5% (w/v)

Purposes

Oral debriding agent/oral wound cleanser

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

Warnings

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

When using this product, do not swallow.

Stop use and ask a doctor if

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

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

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

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

Other Information

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

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:

COLGATE-PALMOLIVE COMPANY

New York, NY 10022

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

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

INGREDIENTS AND APPEARANCE

PEROXYL MOUTH SORE MILD MINT

hydrogen peroxide rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0126-0083
Route of Administration	BUCCAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 338 (UNII: F75JV2T505)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE (Light Blue Solution with the Smell of Mint)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0126-0083-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2009
2	NDC:0126-0083-99	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2015
3	NDC:0126-0083-70	50 in 1 CARTON	03/15/2017
3		10 mL in 1 POUCH; Type 0: Not a Combination Product
4	NDC:0126-0083-31	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2020
5	NDC:0126-0083-22	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	01/01/2009

Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)

Revised: 12/2019

Document Id: 56331d75-a18b-434d-a26c-0ee9cf160d55

Set id: b1e1b7c9-dea7-4d64-b6a8-5343f4176359

Version: 12

Effective Time: 20191210

Search by Drug Name or NDC

NDC 00126-0083-16 Peroxyl Mouth Sore Mild Mint 15 mg/mL Details

Peroxyl Mouth Sore Mild Mint 15 mg/mL

Product Information

Package

Package Images

NDC 00126-0083-16 (00126008316)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b1e1b7c9-dea7-4d64-b6a8-5343f4176359 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purposes

Uses

Warnings

Stop use and ask a doctor if

Directions

Inactive ingredients

Other Information

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

INGREDIENTS AND APPEARANCE

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