Peroxyl®

Peroxyl®
SPL v18
SPL
SPL Set ID b1e1b7c9-dea7-4d64-b6a8-5343f4176359
Route
BUCCAL
Published
Effective Date 2024-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (15 mg)
Inactive Ingredients
Water Sorbitol Propylene Glycol Poloxamer 338 Polysorbate 20 Saccharin Sodium Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-01-01 Until 2024-11-25

Description

Drug Facts

Purpose

Oral debriding agent/oral wound cleanser


Medication Information

Purpose

Oral debriding agent/oral wound cleanser

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50567-7

When using this product, do not swallow.

Section 50570-1

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

Purposes

Oral debriding agent/oral wound cleanser

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
Questions?

1-800-468-6502

Active Ingredient

Hydrogen peroxide 1.5% (w/v)

Other Information

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

Inactive Ingredients

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

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
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 50 Dose Packet Carton

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


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50567-7 (50567-7)

When using this product, do not swallow.

Section 50570-1 (50570-1)

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

Purposes

Oral debriding agent/oral wound cleanser

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
Questions?

1-800-468-6502

Active Ingredient (Active ingredient)

Hydrogen peroxide 1.5% (w/v)

Other Information

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

Inactive Ingredients (Inactive ingredients)

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

Stop Use and Ask A Doctor If (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
Principal Display Panel 500 Ml Bottle Label (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 50 Dose Packet Carton (PRINCIPAL DISPLAY PANEL - 50 Dose Packet Carton)

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


Advanced Ingredient Data


Raw Label Data

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