SPL v3
SPL
SPL Set ID f2ea4e1b-a3d7-d063-e053-2a95a90a6d0b
Route
ORAL
Published
Effective Date 2023-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Policresulen (720 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-01-23

Description

Policresulen Solution


Medication Information

Warnings and Precautions

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.

Do not use if carton is opened. Do not use if printed band on bottle is broken or missing

Indications and Usage

Adults and children 2 years of age and older: rinse half of a capful 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. To open child safety cap, squeeze smooth sides while turning. Reclose tightly

Dosage and Administration

for oral use

Description

Policresulen Solution

Section 50565-1

Keep out of reach of children

Section 51727-6

Water; Sorbitol; Propylene Glycol; Poloxamer

Section 51945-4

Section 55105-1

Oral debriding agent/oral wound cleanser 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 such as mouth burns, cheek bites and toothbrush abrasions. Cleans minor mouth wounds by removing foreign materials that can impede the healing process

Section 55106-9

Policresulen Solution


Structured Label Content

Indications and Usage (34067-9)

Adults and children 2 years of age and older: rinse half of a capful 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. To open child safety cap, squeeze smooth sides while turning. Reclose tightly

Dosage and Administration (34068-7)

for oral use

Warnings and Precautions (34071-1)

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.

Do not use if carton is opened. Do not use if printed band on bottle is broken or missing

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Water; Sorbitol; Propylene Glycol; Poloxamer

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Oral debriding agent/oral wound cleanser 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 such as mouth burns, cheek bites and toothbrush abrasions. Cleans minor mouth wounds by removing foreign materials that can impede the healing process

Section 55106-9 (55106-9)

Policresulen Solution


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)