ACT Anticavity Fluoride Rinse Kids Spongebob

ACT Anticavity Fluoride Kids Spongebob by

Drug Labeling and Warnings

ACT Anticavity Fluoride Kids Spongebob by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Chattem Plant 3. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACT ANTICAVITY FLUORIDE KIDS SPONGEBOB- 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.

----------

ACT Anticavity Fluoride Rinse Kids Spongebob

Drug Facts

Active Ingredients

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 line 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, sodium benzoate, sodium phosphate, sorbitol, sucralose, water (283-039)

Learn more at www.ACTFLUORIDE.com

PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
KID”S RINSE BRAND
ACT®
Kids
Anitcavity
Fluoride Rinse
OCEAN BERRY
nickelodeon
SpongeBOB
SQUAREPANTS
Sodium Fluoride 0.05%
16.9 fl oz (500 mL)

#1 DENTIST RECOMMENDED KID”S RINSE BRAND ACT® Kids Anitcavity Fluoride Rinse OCEAN BERRY nickelodeon SpongeBOB SQUAREPANTS Sodium Fluoride 0.05% 16.9 fl oz (500 mL)

ACT ANTICAVITY FLUORIDE KIDS SPONGEBOB 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 41167-0935
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
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)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 41167-0935-0500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/01/201002/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/01/201002/28/2019
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 3832973031LABEL(41167-0935) , MANUFACTURE(41167-0935) , PACK(41167-0935)

Revised: 2/2010
Document Id: d161ecfb-4780-4001-9c14-59537db4785b
Set id: 56efc245-9839-4a11-b89b-5f57539fd0f3
Version: 8
Effective Time: 20100201
 
Chattem, Inc.