ACT ANTICAVITY FLUORIDE KIDS GROOVY GRAPE- sodium fluoride rinse 
Chattem, Inc.

----------

ACT Anticavity Fluoride Rinse Kids Groovy Grape

ACT

Anticavity Kids Rinse Groovy Grape 0.05%

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

PRINCIPAL DISPLAY PANEL

ACT
Kids
ANTICAVITY
FLUORIDE RINSE
GROOVY GRAPE
16.9 fl oz (500 mL)

ACT
Kids
ANTICAVITY
FLUORIDE RINSE
GROOVY GRAPE
16.9 fl oz (500 mL)

ACT ANTICAVITY FLUORIDE KIDS GROOVY GRAPE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0945
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
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    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0945-0500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02104/01/2019
Labeler - Chattem, Inc. (003336013)

Revised: 10/2023
Document Id: 5db218b4-db59-40ad-a605-b9ae1e312bca
Set id: cd167c0b-2086-4204-b0ac-90df404bd4bb
Version: 4
Effective Time: 20231009
 
Chattem, Inc.