ACT ANTICAVITY KIDS ICARLY FLUORIDE- sodium fluoride rinse
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.

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ACT Anticavity Fluoride Rinse Kids iCarly

Drug Facts

Active Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

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

Directions

adults and children 6 years of age and older:

use once a day after brushing your teeth with a toothpaste
remove cap
hold bottle upright and squeeze. Fill to FILL LINE
pour out. Only the correct 10 milliliters dose will pour out.
vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision

children under 6 years of age: consult a dentist or doctor

Other information

do not use

if safety seal is broken or missing

Inactive ingredients

benzyl alcohol, blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, red 33, sodium benzoate, sodium phosphate, sorbitol, sucralose, water (283-113)

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED FLUORIDE BRAND†
NEW!
ACT® Anticavity KIDS
ALCOHOL FREE FLUORIDE RINSE
nickelodeon iCarlyTM
iBerry Blast
Sodium Fluoride 0.05%
IMPORTANT: Read directions for proper use
16.9 fl oz (500mL)

PRINCIPAL DISPLAY PANEL
ACT® Anticavity KIDS nickelodeon iCarlyTM
iBerry Blast Sodium Fluoride 0.05%
16.9 fl oz (500mL)

ACT ANTICAVITY KIDS ICARLY FLUORIDE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0936
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
PHOSPHATE ION (UNII: NK08V8K8HR)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0936-1	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/01/2011	05/24/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	02/01/2011	05/24/2017

Labeler - Chattem, Inc. (003336013)

Name	Address	ID/FEI	Business Operations
Establishment
Chattem Plant 3		832973031	MANUFACTURE(41167-0936)

Revised: 5/2017

Document Id: c813aef3-cf04-4ffe-8408-8a433297eb09

Set id: dacbdb77-a153-4e40-8ecd-05043882bc19

Version: 2

Effective Time: 20170529

Chattem, Inc.