ACT KIDS ANTICAVITY FLUORIDE GROOVY GRAPE- sodium fluoride paste, dentifrice

ACT Kids Anticavity Fluoride Groovy Grape by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ACT Kids

Anticavity Fluoride Toothpaste

Groovy Grape

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 the 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 years as necessary and use a pea-sized amount until your child is capable of using without supervision.
• children under 2 years of age: consult a dentist or doctor

Inactive ingredients

water, sorbitol, hydrated silica, hydroxyethylcellulose, flavor, sucralose, benzoic acid, sodium saccharin, potassium hydroxide, sodium benzoate, dipotassium glycyrrhizate, sodium lauryl sulfate, red 33, blue 1

PRINCIPAL DISPLAY PANEL

ACT
Kids
NEW
ANTICAVITY
FLUORIDE
TOOTHPASTE
GROOVY
Grape
NET WT 4.6 OZ (130 g)

INGREDIENTS AND APPEARANCE

ACT KIDS ANTICAVITY FLUORIDE GROOVY GRAPE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0926
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0926-1	130 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/01/2021

Labeler - Chattem, Inc. (003336013)