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

Purpose

Antigingivitis, Antiplaque

Description

Cetylpyridinium Chloride 0.07%


Medication Information

Warnings

For this product

Purpose

Antigingivitis, Antiplaque

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
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

Description

Cetylpyridinium Chloride 0.07%

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

Use

helps control plaque that leads to gingivitis

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%

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

Warnings

For this product

Purpose

Antigingivitis, Antiplaque

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
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

Use

helps control plaque that leads to gingivitis

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%

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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