SPL v1
SPL
SPL Set ID 3fb1a2ee-381e-a9e8-e063-6394a90a864b
Route
ORAL
Published
Effective Date 2025-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (2.29 g)
Inactive Ingredients
Water Propylene Glycol Glycerin Peg-40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Active ingredient(s) Cetylpyridinium Chloride 2.296%


Medication Information

Warnings and Precautions

Warnings

■ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Use(s)

■ Refreshing the mouth

■ Plaque removal

■ Oral cleanliness

■ Bad breath removal

Dosage and Administration

Directions

Adults and children 6 years of age and older:

■ use twice a day after brushing your teeth with a toothpaste

■ vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out

■ do not swallow the rinse

■ do not eat or drink for 30 minutes after rinsing

■ instruct children under 12 years of age in good rinsing habits (to minimize swallowing)

■supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

Description

Active ingredient(s) Cetylpyridinium Chloride 2.296%

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive ingredients

Water, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Glycerin, Sodium Saccharin, Sodium Citrate, Herb-Mint Flavor, Menthol, Mentha Piperita Oil, Xylitol, Sucralose, Citric Acid, Melaleuca Alternifolia Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Eucalyptus Globulus Leaf Extract, Camellia Sinensis Leaf Extract, Brilliant Blue FCF

Section 51945-4

Section 53413-1

Questions

■ https://acuseplanet.cafe24.com/shop2/

■ Customer center : 82-70-8065-7737

Section 55105-1

Purpose

Antiplaque

Section 55106-9

Active ingredient(s)

Cetylpyridinium Chloride 2.296%

Section 60561-8

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light


Structured Label Content

Indications and Usage (34067-9)

Use(s)

■ Refreshing the mouth

■ Plaque removal

■ Oral cleanliness

■ Bad breath removal

Dosage and Administration (34068-7)

Directions

Adults and children 6 years of age and older:

■ use twice a day after brushing your teeth with a toothpaste

■ vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out

■ do not swallow the rinse

■ do not eat or drink for 30 minutes after rinsing

■ instruct children under 12 years of age in good rinsing habits (to minimize swallowing)

■supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

Warnings and Precautions (34071-1)

Warnings

■ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive ingredients

Water, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Glycerin, Sodium Saccharin, Sodium Citrate, Herb-Mint Flavor, Menthol, Mentha Piperita Oil, Xylitol, Sucralose, Citric Acid, Melaleuca Alternifolia Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Eucalyptus Globulus Leaf Extract, Camellia Sinensis Leaf Extract, Brilliant Blue FCF

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

■ https://acuseplanet.cafe24.com/shop2/

■ Customer center : 82-70-8065-7737

Section 55105-1 (55105-1)

Purpose

Antiplaque

Section 55106-9 (55106-9)

Active ingredient(s)

Cetylpyridinium Chloride 2.296%

Section 60561-8 (60561-8)

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)