REACH ANTI CAVITY 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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Reach Essentials Anti-Cavity Fluoride RinseDrug Facts

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

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 mL of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat of 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

store at room temperature 59-86°F (15-30°C)
cold weather may temporarily cloud product, shake well if this occurs
do not use if printed safety seal is broken or missing.

Inactive ingredients

purified water, glycerin, propylene glycol, PEG-40 hydrogenated castor oil, poloxamer 407, sodium benzoate, flavor, cetylpyridinium chloride, sucralose, citric acid, disodium phosphate, FD&C blue #1

Questions?

1-866-373-7374 or comments@ranir.com

Package/Label Principal Display Panel

REACH® ESSENTIALS™

ANTI-CAVITY

FLUORIDE RINSE

6 IN 1 BENEFITS

- Freshens Breath

- Cleans Mouth

- Strengthens Teeth

- Fights Acid Wear

- Prevents Cavities

- Alcohol-Free

ARCTIC MINT

IMPORTANT: Read directions for proper use

13.5 FL OZ (400 mL)

reach-anticavity-fluoride-rinse-front
reach-anticavity-fluoride-rinse-back
REACH ANTI CAVITY FLUORIDE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66923-300
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66923-300-08400 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2021
2NDC:66923-300-641000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/22/2021
Labeler - Ranir LLC (364567615)

Revised: 6/2022
Document Id: 49978130-5004-476f-9b2b-a095f8906c67
Set id: 49978130-5004-476f-9b2b-a095f8906c67
Version: 1
Effective Time: 20220627
 
Ranir LLC