ACT ADVANCED CARE PLAQUE GUARD ANTIGINGIVITIS ANTIPLAQUE CLEAN MINT- cetylpyridinium chloride mouthwash 
ACT ADVANCED CARE PLAQUE GUARD ANTIGINGIVITIS ANTIPLAQUE FROSTED MINT- cetylpyridinium chloride mouthwash 
Chattem, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACT Advanced Care Plaque Guard Antigingivitis Antiplaque Mouthwash

ACT Advanced Care Plaque Guard
Antigingivits/Antiplaque Mouthwash- Clean Mint

Drug Facts

Active ingredient

Cetylpyridinium chloride 0.07% 

Purpose

Antigingivitis/Antiplaque 

Uses

  • helps prevent and reduce plaque and gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums

Warnings

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 increasing spacing between the teeth. These
    may be signs or symptoms of periodontitis, a serous 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. 

Directions

  • use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to using this rinse

adults and children 6 years of age and older:

  • vigorously swish 20 mL (4 teaspoonfuls) of rinse between your teeth for 30 seconds twice a day and then spit out.  Do not swallow the rinse.

children 6 to 12 years of age: adults should supervise use
children under 6 years of age: consult a dentist or doctor

Other information

  • do not use if safety seal is broken or missing

Inactive ingredients

water, xylitol, propylene glycol, flavor, sucralose, PEG‑35 castor oil, dipotassium glycyrrhizate, yellow 5, green 3 (309-112)

ACT Advanced Care Plaque Guard
Antigingivits/Antiplaque Mouthwash- Frosted Mint

Drug Facts

Active ingredient

 Cetylpyridinium chloride 0.07%

Purpose

 Antigingivitis/Antiplaque

Uses

  • helps prevent and reduce plaque and gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums

Warnings

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 increasing spacing between the teeth.  These
    may be signs or symptoms of periodontitis, a serous 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.

Directions

  • use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to using this rinse

adults and children 6 years of age and older:

  • vigorously swish 20 mL (4 teaspoonfuls) of rinse between your teeth for 30 seconds twice a day and then spit out.  Do not swallow the rinse.

children 6 to 12 years of age: adults should supervise use
children under 6 years of age: consult a dentist or doctor

Other information

  • do not use if safety seal is broken or missing

Inactive ingredients

water, alcohol (11%), xylitol, propylene glycol, flavor, sucralose, PEG‑35 castor oil, dipotassium glycyrrhizate, blue 1 (309-113)

Principal Display Panel

ACT
Advanced Care Plaque Guard
Antigingivits/Antiplaque Mouthwash
Kills Germs
Helps Prevent Plaque       
Helps Control Gingivitis
Freshens Breath
Clean Mint
18 fl oz (532 mL)

ACT Advanced Care Plaque Guard Antigingivits/Antiplaque Mouthwash Kills Germs Helps Prevent Plaque Helps Control Gingivitis Freshens Breath Clean Mint 18 fl oz (532 mL)

Principal Display Panel
ACT
Advanced Care Plaque Guard
Antigingivits/Antiplaque Mouthwash
Kills Germs
Helps Prevent Plaque       
Helps Control Gingivitis
Freshens Breath
Frosted Mint
18 fl oz (532 mL)

ACT Advanced Care Plaque Guard Antigingivits/Antiplaque Mouthwash Kills Germs Helps Prevent Plaque Helps Control Gingivitis Freshens Breath Frosted Mint 18 fl oz (532 mL)
ACT ADVANCED CARE PLAQUE GUARD ANTIGINGIVITIS ANTIPLAQUE  CLEAN MINT
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0955
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0955-0532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/201509/22/2021
2NDC:41167-0955-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/201509/22/2021
3NDC:41167-0955-330 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/201509/22/2021
4NDC:41167-0955-888 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/201509/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/02/201509/22/2021
ACT ADVANCED CARE PLAQUE GUARD ANTIGINGIVITIS ANTIPLAQUE  FROSTED MINT
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0954
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
XYLITOL (UNII: VCQ006KQ1E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0954-0532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/201501/22/2021
2NDC:41167-0954-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/201501/22/2021
3NDC:41167-0954-588 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/201501/22/2021
4NDC:41167-0954-830 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/201501/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/02/201501/22/2021
Labeler - Chattem, Inc. (003336013)

Revised: 2/2015
 
Chattem, Inc.