ACT ®  Dry Mouth  Anticavity Fluoride Toothpaste

ACT Dry Mouth Anticavity Fluoride by

Drug Labeling and Warnings

ACT Dry Mouth Anticavity Fluoride by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACT DRY MOUTH ANTICAVITY FLUORIDE- sodium fluoride paste, dentifrice 
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®  Dry Mouth 
Anticavity Fluoride Toothpaste

 Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.14% w/v fluoride ion) 

Purpose

Anticavity 

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children under 6 years of age.

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

Directions

• adults and children 2 years of age and older:  brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.  Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).  Supervise children under 6 as necessary and use a pea-sized amount until your child is capable of using without supervision.
• children under 2 years of age:  do not use unless directed by a dentist or doctor

Inactive ingredients

water, glycerin, xylitol, hydrated silica, cocamidopropyl betaine, xanthan gum, 4-t-butylcyclohexanol, dipotassium glycyrrhizate, titanium dioxide, carbomer, sucralose, flavors, pentylene glycol, benzoic acid, sodium benzoate

Principal Display Panel
ACT
Dry Mouth
Anticavity Fluoride
Toothpaste
NET WT4.6 OZ (130 g)

ACT DRY MOUTH ANTICAVITY FLUORIDE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0920
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0920-0	1 in 1 CARTON	02/02/2015	11/01/2019
1		130 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41167-0920-4	1 in 1 CARTON	02/02/2015	11/01/2019
2		11 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	02/02/2015	11/01/2019

Labeler - Chattem, Inc. (003336013)

Revised: 12/2019

Document Id: d7a92cf8-9539-40db-93d4-66daefcca25e

34390-5

Set id: 42b3c0d3-8261-42d7-aa3f-996d65908acb

Version: 3

Effective Time: 20191216

 

Chattem, Inc.