TOTAL ADVANCED HEALTH FRESH MINT- cetylpyridinium chloride rinse

Total Advanced Health Fresh Mint by

Drug Labeling and Warnings

Total Advanced Health Fresh Mint by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Cetylpyridinium chloride 0.075%

Purpose

Antigingivitis/antiplaque

Uses

• helps prevent and reduce plaque and gingivitis
• helps control plaque bacteria that contribute to the development of gingivitis 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 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.

Directions

Shake well to mix the two liquids before each use.

• adults and children 12 years of age and 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
• children under 6 years of age: do not use

Other information

• this rinse is not intended to replace brushing or flossing
• store at 59°F to 77°F
• keep from freezing

Inactive ingredients

water, mineral oil, glycerin, sorbitol, flavor, benzyl alcohol, potassium sorbate, sodium benzoate, phosphoric acid, sodium saccharin, sucralose, simethicone, helianthus annuus (sunflower) seed oil, beta carotene, FD&C blue no. 1

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by: COLGATE-PALOLIVE COMPANY
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

SHAKE
TO ACTIVATE

SEE THE RESULTS IN THE SINK

Colgate®
Antigingivitis Antiplaque Mouthwash

Total®

ADVANCED HEALTH
HELPS IMPROVE THE HEALTH OF YOUR MOUTH

• ✓ REDUCES PLAQUE
• ✓ FRESHENS BREATH
• ✓ HELPS PREVENT GINGIVITIS

FRESH MINT
ALCOHOL FREE†

6.7 FL OZ
(200 mL)

P9917057

INGREDIENTS AND APPEARANCE

TOTAL ADVANCED HEALTH FRESH MINT 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-390
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BETA CAROTENE (UNII: 01YAE03M7J)
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: 35000-390-68	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2017
2	NDC: 35000-390-12	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2017
3	NDC: 35000-390-27	800 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	01/09/2017

Labeler - Colgate-Palmolive Company (001344381)