ACT ANTICAVITY FLUORIDE KIDS WILD WATERMELON (sodium fluoride 0.24- 0.14 w/v fluoride ion paste

ACT Anticavity Fluoride Kids Wild Watermelon by

Drug Labeling and Warnings

ACT Anticavity Fluoride Kids Wild Watermelon 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

(Wild Watermelon)

     

Drug Facts

Active ingredient

Purpose

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

Other information

■ contains FD&C yellow no. 5 (tartrazine) as a color additive

Inactive ingredients

water, sorbitol, hydrated silica, hydroxyethylcellulose, flavor, sucralose, benzoic acid, sodium saccharin, potassium hydroxide, sodium benzoate, dipotassium glycyrrhizate, sodium lauryl sulfate, yellow 5, green 3

PRINCIPAL DISPLAY PANEL

ACT
Kids
wild
water-
melon
NET WT 4.6 oz (130 g)

INGREDIENTS AND APPEARANCE

ACT ANTICAVITY FLUORIDE KIDS WILD WATERMELON 
sodium fluoride 0.24 (0.14 w/v fluoride ion) paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0924
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
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)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0924-2	130 g in 1 TUBE; Type 0: Not a Combination Product	05/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	05/21/2019

Labeler - Chattem, Inc. (003336013)