REACH ANTI CAVITY FLUORIDE- sodium fluoride rinse

Reach Anti cavity Fluoride by

Drug Labeling and Warnings

Reach Anti cavity Fluoride by is a Otc medication manufactured, distributed, or labeled by Ranir LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

REACH ANTI CAVITY FLUORIDE 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66923-300
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66923-300-08	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/22/2021
2	NDC: 66923-300-64	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/22/2021

Labeler - Ranir LLC (364567615)