SPL v2
SPL
SPL Set ID 3f47d7e1-b6ae-efd1-e063-6394a90a4602
Route
DENTAL
Published
Effective Date 2025-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.05 mg)
Inactive Ingredients
Sodium Benzoate Sorbitol Camellia Sinensis Leaf Menthol Glycyrrhiza Uralensis Sodium Citrate Glycerin Fragrance Mint Orc2000774 Lonicera Japonica Flower Peg-40 Hydrogenated Castor Oil Sucralose Prunus Speciosa Flower Water Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-21

Description

Cetylpyridinium chloride 0.05% (w/w)


Medication Information

Warnings and Precautions

For oral use only. Do not swallow.

Accidental ingestion of small amounts is not expected to cause harm.

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or allergic reaction occurs.

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

Indications and Usage

Helps reduce bacteria in the mouth that may cause bad breath and oral discomfort.

Dosage and Administration

Adults and children 6 years and older:

Use after brushing. Tear open one pouch and pour into mouth. Gargle for 20 seconds, then spit out. Do not rinse with water.

Children under 6 years:

Use only under the supervision of a dentist or physician.

Description

Cetylpyridinium chloride 0.05% (w/w)

Section 50565-1

keep out of reach of children section

Section 51727-6

Purified water, Sorbitol, PEG-40 hydrogenated castor oil, Glycerin, Propylparaben, Fragrance, Sodium benzoate, Lonicera japonica flower extract, Prunus speciosa flower extract, Glycyrrhiza uralensis extract, Camellia sinensis polyphenols, Sodium citrate, Menthol, Sucralose.

Section 51945-4

Section 55105-1

Oral antiseptic

Section 55106-9

Cetylpyridinium chloride 0.05% (w/w)


Structured Label Content

Indications and Usage (34067-9)

Helps reduce bacteria in the mouth that may cause bad breath and oral discomfort.

Dosage and Administration (34068-7)

Adults and children 6 years and older:

Use after brushing. Tear open one pouch and pour into mouth. Gargle for 20 seconds, then spit out. Do not rinse with water.

Children under 6 years:

Use only under the supervision of a dentist or physician.

Warnings and Precautions (34071-1)

For oral use only. Do not swallow.

Accidental ingestion of small amounts is not expected to cause harm.

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or allergic reaction occurs.

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

Section 50565-1 (50565-1)

keep out of reach of children section

Section 51727-6 (51727-6)

Purified water, Sorbitol, PEG-40 hydrogenated castor oil, Glycerin, Propylparaben, Fragrance, Sodium benzoate, Lonicera japonica flower extract, Prunus speciosa flower extract, Glycyrrhiza uralensis extract, Camellia sinensis polyphenols, Sodium citrate, Menthol, Sucralose.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Oral antiseptic

Section 55106-9 (55106-9)

Cetylpyridinium chloride 0.05% (w/w)


Advanced Ingredient Data


Raw Label Data

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