SPL v3
SPL
SPL Set ID 3f4ee467-8142-8cb7-e063-6394a90aa7f7
Route
DENTAL
Published
Effective Date 2025-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.06 g)
Inactive Ingredients
Panax Notoginseng Whole Ectoin Cellulose Gum Portulaca Oleracea Whole Water Scutellaria Baicalensis Whole Peg-40 Hydrogenated Castor Oil Sodium Benzoate Sorbitol Strontium Chloride Lonicera Japonica Flower

Identifiers & Packaging

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

Description

Cetylpyridinium chloride 0.06% (w/w)


Medication Information

Warnings and Precautions

For oral use only. Do not swallow.

Do not use in children under 6 years of age unless directed by a dentist or physician.

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

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

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

Single-use only.

Indications and Usage

Adults and children 6 years and older:

Apply a small amount of gel to the gums and teeth using a cotton swab or clean finger.

Allow it to remain in place for at least 30 minutes before rinsing, eating, or drinking.

Children under 6 years: Use only under the supervision of a dentist or physician.

For post-procedure care (tooth extraction, implant), follow dentist's instructions.

Dosage and Administration

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

Description

Cetylpyridinium chloride 0.06% (w/w)

Section 50565-1

keep out of reach of children

Section 51727-6

Sorbitol, Purified water, Ectoin, Cellulose gum, Glycerin, PEG-40 hydrogenated castor oil, Sodium benzoate, Strontium chloride, Panax notoginseng extract, Lonicera japonica (honeysuckle) flower extract, Portulaca oleracea (purslane) extract, Scutellaria baicalensis extract.

Section 51945-4

Section 55105-1

Oral antiseptic

Section 55106-9

Cetylpyridinium chloride 0.06% (w/w)

Section 60561-8

Store at room temperature away from light and moisture.

Do not use if seal is broken.

Expiration date: See outer package.


Structured Label Content

Indications and Usage (34067-9)

Adults and children 6 years and older:

Apply a small amount of gel to the gums and teeth using a cotton swab or clean finger.

Allow it to remain in place for at least 30 minutes before rinsing, eating, or drinking.

Children under 6 years: Use only under the supervision of a dentist or physician.

For post-procedure care (tooth extraction, implant), follow dentist's instructions.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For oral use only. Do not swallow.

Do not use in children under 6 years of age unless directed by a dentist or physician.

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

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

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

Single-use only.

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

Sorbitol, Purified water, Ectoin, Cellulose gum, Glycerin, PEG-40 hydrogenated castor oil, Sodium benzoate, Strontium chloride, Panax notoginseng extract, Lonicera japonica (honeysuckle) flower extract, Portulaca oleracea (purslane) extract, Scutellaria baicalensis extract.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Oral antiseptic

Section 55106-9 (55106-9)

Cetylpyridinium chloride 0.06% (w/w)

Section 60561-8 (60561-8)

Store at room temperature away from light and moisture.

Do not use if seal is broken.

Expiration date: See outer package.


Advanced Ingredient Data


Raw Label Data

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