ACT Advanced Care Plaque Guard Antigingivitis Antiplaque Clean Mint: Package Insert and Label Information

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.

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

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

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 Mint18 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)
(click image for full-size original)

Principal Display Panel
ACT
Advanced Care Plaque Guard
Antigingivits/Antiplaque Mouthwash
Kills Germs
Helps Prevent Plaque
Helps Control Gingivitis
Freshens Breath
Frosted Mint18 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)
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE 0.7 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
XYLITOL
PROPYLENE GLYCOL
SUCRALOSE
POLYOXYL 35 CASTOR OIL
GLYCYRRHIZINATE DIPOTASSIUM
FD&C YELLOW NO. 5
FD&C GREEN NO. 3
Product Characteristics
Color GREEN Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0955-0 532 mL in 1 BOTTLE, PLASTIC None
2 NDC:41167-0955-1 1000 mL in 1 BOTTLE, PLASTIC None
3 NDC:41167-0955-3 30 mL in 1 BOTTLE, PLASTIC None
4 NDC:41167-0955-8 88 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 02/02/2015 09/22/2021
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE 0.7 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
XYLITOL
PROPYLENE GLYCOL
SUCRALOSE
POLYOXYL 35 CASTOR OIL
GLYCYRRHIZINATE DIPOTASSIUM
FD&C BLUE NO. 1
Product Characteristics
Color BLUE Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0954-0 532 mL in 1 BOTTLE, PLASTIC None
2 NDC:41167-0954-1 1000 mL in 1 BOTTLE, PLASTIC None
3 NDC:41167-0954-5 88 mL in 1 BOTTLE, PLASTIC None
4 NDC:41167-0954-8 30 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 02/02/2015 01/22/2021
Labeler — Chattem, Inc. (003336013)

Revised: 02/2015 Chattem, Inc.

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