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.
Children 2 to 6 years of age: 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, sorbitol, hydrated silica, hydroxyethylcellulose, sucralose, flavor, benzoic acid, sodium saccharin, potassium hydroxide, sodium benzoate, dipotassium glycyrrhizate, sodium lauryl sulfate, red 33

PRINCIPAL DISPLAY PANEL

ACT
Kids
BUBBLE
GUM
BLOWOUT
NET WT 4.6 oz (130 g)

ACT KIDS ANTICAVITY FLUORIDE BUBBLE GUM BLOWOUT
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0922
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41167-0922-2	130 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2016
2	NDC:41167-0922-4	11 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	11/01/2016

Labeler - Chattem, Inc. (003336013)

ACT Kids Toothpaste Bubblegum Blowout