ACT ADVANCED CARE PLAQUE GUARD ANTIGINGIVITIS ANTIPLAQUE CLEAN MINT- cetylpyridinium chloride mouthwash ACT ADVANCED CARE PLAQUE GUARD ANTIGINGIVITIS ANTIPLAQUE FROSTED MINT- cetylpyridinium chloride mouthwash

ACT Advanced Care Plaque Guard Antigingivitis Antiplaque by

Drug Labeling and Warnings

ACT Advanced Care Plaque Guard Antigingivitis Antiplaque by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

SPL UNCLASSIFIED SECTION

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

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)

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

ACT ADVANCED CARE PLAQUE GUARD ANTIGINGIVITIS ANTIPLAQUE  CLEAN MINT
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0955
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0955-0	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 41167-0955-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 41167-0955-3	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 41167-0955-8	88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	02/02/2015

ACT ADVANCED CARE PLAQUE GUARD ANTIGINGIVITIS ANTIPLAQUE  FROSTED MINT
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0954
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0954-0	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 41167-0954-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 41167-0954-5	88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 41167-0954-8	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	02/02/2015

Labeler - Chattem, Inc. (003336013)