ACT Kids Anticavity Fluoride

Manufacturer: Chattem, Inc.
Effective date: 2024-12-01
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 00:53:54

Label at a glance#

ProductACT Kids Anticavity Fluoride Bubble Gum Blowout

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Dosage and administration

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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ACT^® Kids

Anticavity Fluoride Toothpaste

Bubblegum Blowout

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41167-0922-2	ACT Kids Anticavity FluorideBubble Gum Blowout	130 g in 1 TUBE	PASTE	130		8
41167-0922-4	ACT Kids Anticavity FluorideBubble Gum Blowout	11 g in 1 TUBE	PASTE	11		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-0922	ACT KIDS ANTICAVITY FLUORIDE BUBBLE GUM BLOWOUT (SODIUM FLUORIDE) PASTE [CHATTEM, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250130_61f3a3e6-645b-4368-b1d5-7de1fc14542e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

ACT Kids Anticavity Fluoride Bubble Gum Blowout
sodium fluoride
FLUORIDE ION
WATER
SORBITOL
HYDRATED SILICA
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)
SUCRALOSE
BENZOIC ACID
SACCHARIN SODIUM
POTASSIUM HYDROXIDE
SODIUM BENZOATE
GLYCYRRHIZINATE DIPOTASSIUM
SODIUM LAURYL SULFATE
D&C RED NO. 33

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41167-0922	41167-0922-2, 41167-0922-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)	L605B5892V	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
GLYCYRRHIZINATE DIPOTASSIUM	CA2Y0FE3FX	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACT Kids Anticavity Fluoride Bubble Gum Blowout	SODIUM FLUORIDE	Chattem, Inc.	61f3a3e6-645b-4368-b1d5-7de1fc14542e	2024-12-01	Warnings	Exact identifier ndc (package): 41167-0922-4 ndc (package): 41167-0922-2 ndc (product): 41167-0922 ndc11 (package): 41167092204 ndc11 (package): 41167092202 spl id: ea287112-f84f-4710-a126-c821481d5793 spl set id: 61f3a3e6-645b-4368-b1d5-7de1fc14542e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.