FIREFLY ANTICAVITY FLUORIDE- sodium fluoride rinse 
Ranir LLC

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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FIREFLY Anticavity Fluoride Rinse Paw Patrol Drug Facts

Active ingredient

Sodium Fluoride 0.05%

Purpose

Anticavity rinse

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
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

recommended storage temperature 59°-86°F(15°-30°C)
do not use if printed plastic neckband is broken or missing

Inactive Ingredients

cetylpyridinium chloride, citric acid, disodium EDTA, disodium phosphate, FD&C blue#1, flavor, menthol, poloxamer 407, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium phosphate, sorbitol, sucralose, xylitol

Questions?

Toll Free: 1-866-373-7374

Principal Display Panel

FIREFLY™ ANTICAVITY Fluoride Rinse

PAW PATROL™

BUBBLE GUM

nickelodeon

Helps PREVENT CAVITIES

ADA Accepted American Dental Association

Helps prevent cavities

Alcohol FREE

IMPORTANT: Read directions for proper use.

16 FL OZ (473 mL)

firefly-anticavity-fluoride-rinse-front
firefly-anticavity-fluoride-rinse-back
FIREFLY ANTICAVITY FLUORIDE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66923-003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66923-003-43473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021
2NDC:66923-003-34237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/16/2021
Labeler - Ranir LLC (364567615)

Revised: 12/2021
Document Id: e91ed8a1-0d45-402c-9c16-1ae72e695a37
Set id: e91ed8a1-0d45-402c-9c16-1ae72e695a37
Version: 1
Effective Time: 20211221
 
Ranir LLC