Swan D00.001/d00aa

Swan D00.001/d00aa
SPL v2
SPL
SPL Set ID a66d8d21-1ebf-45e6-97bd-dbe17ee67162
Route
ORAL
Published
Effective Date 2025-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.7 mg)
Inactive Ingredients
Water Glycerin Zinc Lactate Benzoic Acid Saccharin Sodium Sucralose Sodium Benzoate Poloxamer 407 Cinnamaldehyde Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Cetylpyridinium Chloride 0.07%

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Cetylpyridinium Chloride 0.07%

Use

helps control plaque that leads to gingivitis

Warnings

For this product

Directions
  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use
Disclaimer

This may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ® Pro-Health ® CPC Antiginigivitis/Antiplaque Oral Rinse Gum and Breath Purify Smooth Mint.

Adverse Reaction

Distributed by:

Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Active Ingredient

Cetylpyridinium Chloride 0.07%

Other Information
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients

water, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1

Principal Display Panel

SWAN ®

COMPARE TO Crest ® Pro Health ®*

$1.25

GUM DEFENSE

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE

SMOOTH MINT

  • Helps reduce early signs of gum disease
  • Kills the germs that cause bad breath
  • Alcohol free

500 mL (1.05 PT) 16.9 FL OZ

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Stop Use and Ask A Dentist If
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep Out of Reach of Children Under 6 Years of Age.

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


Structured Label Content

Use

helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

For this product

Directions
  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use
Disclaimer

This may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ® Pro-Health ® CPC Antiginigivitis/Antiplaque Oral Rinse Gum and Breath Purify Smooth Mint.

Adverse Reaction (Adverse reaction)

Distributed by:

Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Active Ingredient

Cetylpyridinium Chloride 0.07%

Other Information (Other information)
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients (Inactive ingredients)

water, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1

Principal Display Panel (Principal display panel)

SWAN ®

COMPARE TO Crest ® Pro Health ®*

$1.25

GUM DEFENSE

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE

SMOOTH MINT

  • Helps reduce early signs of gum disease
  • Kills the germs that cause bad breath
  • Alcohol free

500 mL (1.05 PT) 16.9 FL OZ

Tamper Evident Statement (Tamper evident statement)

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

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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