Drug Facts

Active ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 6 years of age and older:

use once a day after brushing your teeth with a toothpaste
remove cap
hold bottle upright and squeeze. Fill to FILL LINE
pour out. Only the correct 10 milliliters dose will pour out.
vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision

children under 6 years of age: consult a dentist or doctor

Other information

contains FD&C yellow no. 5 (tartrazine) as a color additive
do not use if safety seal is broken or missing

Inactive ingredients

water, sorbitol, poloxamer 407, propylene glycol, sodium phosphate, disodium phosphate, polysorbate 80, sodium saccharin, flavor, cetylpridinium chloride, calcium disodium EDTA, benzyl alcohol, sodium benzoate, red 33, yellow 5 (309-098)

Learn more at www.ACTFLUORIDE.com

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT
Anitcavity
Fluoride Mouthwash
alcohol free
CINNAMON
18 fl. oz. (532 mL)

PRINCIPAL DISPLAY PANEL
#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT
Anitcavity
Fluoride Mouthwash
alcohol free
CINNAMON
18 fl. oz. (532 mL)

ACT ANTICAVITY FLUORIDE CINNAMON
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0940
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CINNAMON	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0940-8	532 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/01/1994

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	04/01/1994

Labeler - Chattem, Inc. (003336013)

Name	Address	ID/FEI	Business Operations
Establishment
CHATTEM, INC.		832973031	manufacture(41167-0940)

ACT Anticavity Fluoride Rinse Cinnamon