SPL v5
SPL
SPL Set ID c357c8f8-6fd6-c2f8-e053-2995a90a4023
Route
DENTAL
Published
Effective Date 2022-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (15 mg)
Inactive Ingredients
Xylitol Methyl Salicylate Propylene Glycol Polyoxyl 40 Hydrogenated Castor Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-16

Description

Methyl Salicylate, PEG-40, Propylene Glycol, Water, Xylitol

Purpose

Oral Debriding Agent / Oral Wound Cleanser


Medication Information

Purpose

Oral Debriding Agent / Oral Wound Cleanser

Description

Methyl Salicylate, PEG-40, Propylene Glycol, Water, Xylitol

Uses



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

• For temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.

• For temporary use to cleanse canker sores.

• Assists in the removal of foreign material from minor oral wounds.

Section 51945-4

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 dentist or physician if:

• sore mouth symptoms do not improve in 7 days;

• irritation, pain, or redness persists or worsens;

• swelling, rash, or fever develops.

Directions

• Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the 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?

1-855-696-7254

Active Ingredient

Hydrogen Peroxide 1.5% (w/v)

Other Information

Store at controlled room temperatures 68 - 77ºF (20 - 25ºC) and away from direct sunlight. Keep cap tightly closed when not in use.

Inactive Ingredients

Methyl Salicylate, PEG-40, Propylene Glycol, Water, Xylitol

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.


Structured Label Content

Uses



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

• For temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.

• For temporary use to cleanse canker sores.

• Assists in the removal of foreign material from minor oral wounds.

Section 51945-4 (51945-4)

Purpose

Oral Debriding Agent / Oral Wound Cleanser

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 dentist or physician if:

• sore mouth symptoms do not improve in 7 days;

• irritation, pain, or redness persists or worsens;

• swelling, rash, or fever develops.

Directions

• Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the 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?

1-855-696-7254

Active Ingredient

Hydrogen Peroxide 1.5% (w/v)

Other Information

Store at controlled room temperatures 68 - 77ºF (20 - 25ºC) and away from direct sunlight. Keep cap tightly closed when not in use.

Inactive Ingredients

Methyl Salicylate, PEG-40, Propylene Glycol, Water, Xylitol

Keep Out of Reach of Children (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.


Advanced Ingredient Data


Raw Label Data

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